Recalling Firm
The American National Red Cross South Carolina Region
American National Red Cross, Penn-Jersey Region
The Children's Hospital Assoc. Transfusion Medicine Services
Blood Systems, Inc. dba United Blood Services
Cardinal Health, Medical Products & Services
University Of Miami Miller School of Medicine Tissue Bank
The American National Red Cross - Southern Region
DePuy Mitek, Inc., a Johnson & Johnson Co.

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
US states nationwide. International: Canada, U.A.E, Saudi Arabia, Cyprus, UK, France, Germany, Greece, Israel, Italy, S.Africa, Jordan, Kuwait, Lebanon, Poland, Serbia, Croatia, Seria, Montenegro, Austria, Netherlands, Russia, Finland, Spain & Portugal, Turkey, Russia, Finland, Brazil, Argentina, Australia, Qatar, Bangladesh, Korea, China, Chile, Bolivia, Paraguay, Costa Rica, Ecuador, Guatemala, India, Japan, Mexico, Malaysia, New Zealand, Peru Philippines, Pakistan.
Nationwide distribution: USA including states of: IL, CA, WV, TX, SC, WI, NY, PA, NE, NJ, MD, OH, IA, and NC.
Distributed in the states of CA, FL, GA, NJ, and TX.
Product was shipped to the following states: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, MA, MI, MN, MO, NC, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA & WI. Product was also shipped to Canada.
Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.
Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
US Nationwide Distribution including Puerto Rico.
Worldwide distribution: USA (Nationwide) and countries of: Arab Emirates (AE) Ireland (IE), Albania, Israel (IL), Argentina (AR),Italy (IT) Armenia (AM) , Japan (JP), Austria (AT) Jordan (JO), Bahrain (BH) Kuwait (KW) Belgium (BE), Lebanon (LB), Belarus , Netherlands (NL), Brazil (BR),Nigeria (NG), Bulgaria (BG) , Pakistan (PK), Canada (CA) Poland (PL), China (CN) Romania (RO), Columbia (CO), Russia (RU), Cyprus(CY) , Saudi Arabia (SA) Czech (CZ) , Singapore (SG), Denmark (OK), South Korea (KR), Egypt (EG), Spain (ES), Finland (FI), Sri Lanka (LK),Germany (DE) Turkey (TR) Ghana (GH) , Uganda (UG), Great Britain (GB) Ukraine (UA), Greece (GR) Uruguay (UY), and Hong Kong (HK).
Distributed in the states of AR, MS, SC, and TN.
Nationwide Distribution: USA including states of: IL, IN, MA, MI, MO, NJ, NY, OH, OR, PA, SC, TX, VA, WA and WI
US and Belgium, France, Greece, Italy, Portugal, Spain, Germany, Kenya, Martinique, Austria, Brazil, Canada, Czech Republic, Guadeloupe, Ireland, Israel, Kuwait, Latvia, Mexico, Panama, Peru, Saudi Arabia, Thailand, UK, Uruguay, Vietnam
US Distribution to the state of VA only.
Worldwide Distribution - USA including KY, NJ and Internationally to Argnetina, Australia, Belgium,Columbia, India, France, Japan, Jordan, Latvija, Israel, Korea, and Great Britain. For questions regarding this recall call 508-977-3813.
Distribution was made nationwide, including Puerto Rico, Guatemala and Israel. Specific distribution will be reported.
Nationwide Distribution - USA Nationwide including the states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, and WY.
Worldwide Distribution - USA including CA, MS, FL, PA, TN, CO, IL, TX, OH, MI, MA, IL and internationally to Belgium, Canada, Germany, UK
Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.

Product Description
Micro SSP DNA Typing Trays Micro SSP Allele Specific HLA Class I Typing Tray - A*11 Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Micro SSP DNA Typing Trays Micro SSP Allele Specific HLA Class I Typing Tray - A*26 Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Micro SSP DNA Typing Trays Micro SSP High Resolution HLA Class II DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Micro SSP DNA Typing Trays Micro SSP Generic HLA Class II DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Micro SSP DNA Typing Trays Micro SSP Generic HLA Class II DNA Typing Tray - DRB Only Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Micro SSP DNA Typing Trays Micro SSP HLA Class I and II ABDR DNA Typing Tray Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Micro SSP DNA Typing Trays Micro SSP Generic HLA Class II DNA Typing Tray - DRB/DQB1/DPB1 Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Micro SSP DNA Typing Trays Micro SSP Generic HLA Class I and II DNA Typing Tray - ABDRDQ Article Number: SSP_DNAT_PI Rev 18 510(K) Number : BK960062
Red Blood Cells Leukocytes Reduced Washed
Red Blood Cells Leukocytes Reduced. The responsible firm listed on the product label is American Red Cross Blood Services.
Plasma Frozen. The responsible firm listed on the product label is American Red Cross Blood Services.
Red Blood Cells. The responsible firm listed on the product label is American Red Cross Blood Services.
Fresh Frozen Plasma. The responsible firm listed on the product label is American Red Cross Blood Services.
Cryoprecipitated AHF. The responsible firm listed on the product label is American Red Cross Blood Services.
Platelets. The responsible firm listed on the product label is American Red Cross Blood Services.
Blood and Blood Products for Reprocessing
Platelets Pheresis Leukocytes Reduced, Part 1 of 3, Part 2 of 3 and Part 3 of 3.
Blood and Blood Products for Reprocessing Recovered Plasma Cryoprecipitate Reduced.
Recovered Plasma Frozen within 24 Hour of Phlebotomy (Blood and Blood Products for Reprocessing).
Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System, Instruction Manuals: PDD Telescopes, Tricam SL II, and PDD Camera Heads. Used as an optional accessory to white light cystoscopy when used in combination with the diagnostic imaging drug Cysview.
Platelets Pheresis Leukocytes Reduced Irradiated
Red Blood Cells (Apheresis) Leukocytes Reduced
BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton Circle, Sparks, MD 21152 USA www.bd.com/ds EC REP Benex Limited, Pottery Road, Dun Laoghaire, Co. Dublin, Ireland. Assay is indicated for use with asymptomatic and symptomatic individuals to aid in the diagnosis of gonococcal urogenital disease.
Iams Shakeables Gobble em Up With Turkey for Dogs, 6 oz canister, DISTRIBUTED BY: THE IAMS COMPANY, SUBSIDIARY OF THE PROCTER & GAMBLE CINCINNATI, OHIO, 45202
Iams Shakeables Un-baa-lievable With Lamb for Dogs, 6 oz canister, DISTRIBUTED BY: THE IAMS COMPANY, SUBSIDIARY OF THE PROCTER & GAMBLE CINCINNATI, OHIO, 45202
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30 Downward Bend At Proximal End. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8'', Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7'', Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only Product Usage: These devices are indicated for use with a vascular access device for administration and withdrawal of fluids.
A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7'', Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection Site feature is intended to eliminate accidental needle sticks when used in conjunction with an InterLink Cannula as part of an I.V. needless access system.
A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7'', Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; B) Product Code 2N8221: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.1'', Vol. 0.85 mL, Injection Site Male Luer Lock Adapter with Retractable Collar, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; C) Product Code 2N8222: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 8.2'', Vol. 0.57 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; D) Product Code 2N8223: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7'', Vol. 0.40 mL, Injection Site Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; E) Product Code 6N8220: V-LINK Luer Activated Device with VITALSHIELD Protective Coating Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.6'', Vol. 1.0 mL, Catheter Extension Set, Luer Activated Device with Silver for IV Access, Male Luer Lock Adapter with Retractable Collar, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; F) Product Code 6N8222: V-LINK Luer Activated Device with VITALSHIELD Protective Coating Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 8.2'', Vol. 0.5 mL, Catheter Extension Set, Luer Activated Device with Silver for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids.
A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0'', Vol. 1.0 mL, 2 Luer Activated Valves, Male Luer Lock Adapter, Single use only Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids.
Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP panels are designed for use in determining antimicrobial agent susceptibility of aerobic nonenterococcal streptococci (including Streptococcus pneumoniae) and Haemophilus spp.
Wallace Sure-Pro/ Sure-Pro Ultra Embryo Replacement Catheters (with ultrasound) Product Code: PE623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
Wallace Sure-Pro Ultra Embryo Replacement Catheter with Obturator Product Code: PEB623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
Wallace Sure-Pro Ultra Embryo Replacement Catheter with Stylet Product Code:PES623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
Wallace Sure-Pro Two Stage Embryo Replacement Catheter with Obturator PPB623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
Wallace Sure-Pro Two Stage Embryo Replacement Catheter for difficult transfer with Stylet PPS623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
Wallace Sure-Pro Single Stage Embryo Replacement Catheter Product Code: PP623 Sure-Pro Embryo Replacement Catheters are used for the introduction of embryos into the uterine cavity following in vitro fertilization. Sure-Pro Ultra Embryo Replacement Catheters have the added benefit of being visible under ultrasound. These products can be used in either a one- stage or two-stage procedure. In the one-stage procedure, the clinician pushes the inner catheter through the outer sheath and loads the embryo prior to performing the embryo transfer into the uterus. In the two-stage procedure, the clinician places the outer sheath through the cervical canal into the uterus, then loads the embryo in the inner catheter, and advances the inner catheter through the outer sheath to perform the embryo transfer into the uterus.
Liothyronine Sodium Tablets, USP, 5 mcg Rx ONLY, 100 count bottle, Distributed by: PaddockLaboratories, Inc., Minneapolis, MN 55427, NDC 0574-0220-01,
Presource PBDS, Gyn Laparoscopy Kit, Circulator
A) Presource PBDS, Lap Chole, Kit, Clean Up; B) Presource PBDS, Greenwood LeFlore Hosp, Lap Chole, Kit
Presource PBDS, General Laparoscopy, Kit, Circulator
Presource PBDS, Major Abdominal, Kit, Circulator
Presource PBDS, Knee Arthroscopy, Kit, Circulator
Presource PBDS, Extremity, Kit, Circulator
Presource PBDS, Shoulder Arthroscopy, Kit, Circulator
Presource PBDS, Shoulder Procedure, Kit, Circulator
Presource PBDS, Total Hip, Kit, Circulator
Presource PBDS, Total Joint, Kit, Circulator
Presource PBDS, Total Knee, Kit, Circulator
Presource PBDS, Beaufort Memorial Hospital, Anesthesia Circuit, Kit
Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis: Synthes Radial Head Prosthesis System is a two-piece modular system comprised of titanium alloy stem and cobalt chrome components with an integral screw and side-loading application to allow in-situ assembly.
MicroCel 500 Buffer Chamber Distributed by Siemens Healthcare Diagnostics, 725 Potter Street, Berkeley, CA 94710
MicroCel 300 Buffer Chamber Distributed by Siemens Healthcare Diagnostics, 725 Potter Street, Berkeley, CA 94710
FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.
Cypress Medical Products LLC, MediChoice Umbilical cord clamp, sterile; single use; Distributed by Owens & Minor, Mechanicsville, VA. The product is used to clamp the umbilical cord after childbirth.
DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine.
Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.1mg, packaged in 120-ct bottles (NDC 11789-251-10), Lloyd, Shenandoah, IA.
Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.2 mg, packaged in 120-ct bottles (NDC 11789-252-10), Lloyd, Shenandoah, IA.
Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.3 mg, packaged in 120-ct bottles (NDC 11789-253-10), Lloyd, Shenandoah, IA.
Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.4 mg, packaged in 120-ct bottles (NDC 11789-254-10), Lloyd, Shenandoah, IA.
Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.6 mg, packaged in 120-ct bottles (NDC 11789-256-10), Lloyd, Shenandoah, IA.
Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.5 mg, packaged in 120-ct bottles (NDC 11789-255-10), Lloyd, Shenandoah, IA.
Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.7 mg, packaged in 120-ct bottles (NDC 11789-257-10), Lloyd, Shenandoah, IA.
Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 0.8 mg, packaged in 120-ct bottles (NDC 11789-258-10), Lloyd, Shenandoah, IA.
Lloyd Thyro-Tabs, levothyroxine sodium tablets, USP, 1.0 mg, packaged in 120-ct bottles (NDC 11789-268-10), Lloyd, Shenandoah, IA.
Olympus SurgMaster UES-40 electrosurgical unit (''UES-40'') Product Usage: Designed for use in a medical facility under the supervision of a trained physician. It has been designed for general (open) and endoscopic surgery including urology, gynecology, respiratory and gastroenterology in conjunction with Olympus designed electrosurgical accessories, endoscopes (fiberscopes, videoscopes and rigid scopes) applicable for electrosurgery (cutting and coagulation), light sources and other ancillary equipment.
Codman(R) Collins Radioparent Sternal Blade Nylon,4 3/4'' (121 mm) long, 3'' (76 mm) wide, 1 1/2'' (38 mm) deep, REF 50-8081 sternum retractor
ExoShape Soft Tissue Fastener 12 mm x 30 mm REF 1101-00-1230. For use in the fixation of ligaments, tendons or soft tissue grafts to bone.
Plavix 75 mg, 30 count bottle, NDC (54868-4070-0), Rx only, Manufactured by Bristol-Meyers Squibb, Bridgewater, NJ 08807, Distributed by Physicians Total Care, Tulsa, OK 74146.
Maple View Farm Ice Cream, Carolina Crunch, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.
Maple View Farm Ice Cream, Cookies and Cream, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.
Maple View Farm Ice Cream, Cookie Dough, One Fluid Pint (473ml), Maple View Farm Ice Cream Co., LLC, Hillsborough, NC 27278.
Winn Dixie Organic 100% Apple Juice from concentrate with added ingredients, 64-fl oz
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04
QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, , NDC 0409-6629-02
Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73

Code Info
Catalog Identification: SSP1-11 (Lot Number: 002) and SSPR1-11 (Lot Number: 003).
Catalog Identification: SSP1-26 Lot Number: 01A
Catalog Identification: SSP2H Lot Number: 04A and 005
Catalog Identification: SSP2L Lot Number: 007
Catalog Identification: SSP2LB Lot Number: 004
Catalog Identification: SSPABDR (Lot Number: 008 and 009) and SSPABDRX (Lot Number: 008 and 009)
Catalog Identification: SSPDRQP1 Lot Number: 001
Catalog Identification: SSPML02 Lot Number: 003 and 004
The device Instruction Manual recall, which includes: 1) Telescope, 2) Camera Head, and 3) Camera System. Serial Numbers: ZZ2008 ZZ2016 ZZ2012 ZZ2019 TY2024 ZZ2013 TY2026 TY2025 TY2028 TY2021 ZZ2007 ZZ2020 TX2036 TX2033 ZZ2017, and TX2035.
Catalog Number: PO24THGWG01; Lots: 966051, 970753
Part Number: 1773088101; Lot Number CYB03-11; 1 per pouch; 100 pouches per box.
Lot:: KB33411, Exp date: Sep-13; Lot: KB33411A, Exp date: Sep-13
Lot:: KA32111, Exp date: Aug-13; Lot: KA32111A, Exp date: Aug-13
Lot:: KB33611, Exp date: Sep-13; Lot: KB33611A, Exp date: Sep-13
Lot:: KD33611, Exp date: Sep-13 and Lot:: KD33611A, Exp date: Sep-13
Lot:: VKB30711, Exp date: Aug-13 and Lot:: VKB02412, Exp date: Nov-13
Lot:: VKF33611, Exp date: Sep-13 and Lot:: VKF33611A, Exp date: Sep-13
Model UES-40, all serial numbers prior to 7925334 that have not been upgraded.
Individual containers are not coded. Product distributed from Sept. 5, 2012 and April 24, 2013.

Product Quantity
A) Product Code 2N1191: 53,850; B) Product Code 2N1206: 101,900 units
335,273 meters in the US, and 607,137 internationally

Reason for Recall
Micro SSP DNA Typing Trays of HLA Class I and Class II alleles, where null allele entries were not properly verified and may cause misassignment, were distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
Blood product, quality control and distribution/required testing not performed for HIV/HCV Nucleic Acid Test (NAT), was distributed.
Blood products, platelet pheresis leukocytes reduced with an unacceptable pH, were distributed.
Blood products, collected from a donor who was not asked vCJD travel questions, was distributed.
Blood products, collected from a donor who provided a different last name, were distributed.
Blood products, collected from donors whose hematocrits were determined using an analyzer with an invalid QC control, were distributed.
Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood products, collected from a donor who was permanently deferred, were distributed.
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
The recall was initiated because Karl Storz has confirmed that the Photodynamic Diagnosis (PDD) D-Light C System instruction manuals have important safety-related changes.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Blood products, which were not tested for viral markers, were distributed.
Blood product, collected from an autologous donor but incorrectly labeled as a homologous unit, was distributed.
Blood products, with pH below the acceptable level, were distributed.
Blood product, with an unacceptably low red cell recovery rate, was distributed.
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood product, collected from a donor whose medical history screening was not adequately performed, was distributed.
Increased levels of false positives in BD Probe Tech Neisseria gonorrhoeae Q Amplified DNA assay kits.
The firm was notified via consumer complaints that the product contains mold.
Human tissue allografts were processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P.
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Customer complaint investigation confirmed the issue of false skipped wells and false susceptible misreads with A. agalactiae affecting multiple antimicrobial agents on MicroScan Microbiology Systems.
Unable to pass catheter through outer sheath during embryo transfer
Failed Impurities/Degradation Specifications: Perrigo is conducting a wholesale level recall of two batches of this product due to an out of specification impurity result during three month stability testing.
Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
Rh Immune Globulin, lacking assurance of proper temperature maintenance during transit, was distributed.
Human corneal allograft was processed in a manner that could cause contamination or cross-contamination during processing, and well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P.
The Trial Head may come loose from the implant stem during manipulation of the arm during surgery. To date, no adverse events have been reported related to this issue and this recall is not being initiated as a result of adverse events.
MicroCel 500 and MicroCel 300 buffer chambers, with the potential to leak buffer and could cause electrical arcing posing a hazard to the operator, were distributed.
HCT/P allografts, mislabeled with an incorrect expiration date, were distributed.
Blood product, misbranded as Jkb negative, and subsequently determined to be JKb positive, was distributed.
AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.
Cypress Medical Products LLC is voluntarily recalling one lot of the Owens and Minor (O&M) Umbilical Cord Clamps because recent complaints indicate the clamps are breaking upon use. The product may not perform as intended.
Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.
The product Lot number and/or Expiration Date may be illegible or may be erased.
Olympus initiated a software upgrade and enhancement in 2009 and completed the action in 2010. The upgrade and enhancement were initiated due to complaints of overheating, smoke vapors and failure to operate associated with the Olympus SurgMaster electrosurgical unit, model UES-40 (''UES-40'') when used in conjunction with the Olympus WA22557C electrode. The complaint investigations revealed that some users were exceeding the maximum output time beyond the timeframes specified in the labeling. Exceeding the maximum output time can cause the UES-40 to overheat thereby causing the unit to stop working and produce smoke vapors.
There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.
Expiration date on the patient label and date on the product carton were not the same.
Chemical Contamination: Uncharacteristic moldy odor due to presence of 2,4,6-tribromoanisole (TBA).
Undeclared allergens: Peanuts, Almond and Soy (soy lecithin and soybean oil).
Undeclared allergens: Wheat and Soy (soybean oil).
Undeclared allergens: Wheat and Soy (soy lecithin).
The product is being recalled as a precaution because it could have levels of ''patulin'' that exceeds FDA limits.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.