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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. Class II

Reason: Labeled incorrectly as a Blade Up configuration instead of a Blade Down configuration.

DePuy Mitek, Inc., a Johnson & Johnson Co. 20130415 Terminated
Distributed: 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.
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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. Class II

Reason: 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

Olympus America Inc. 20091110 Terminated
Distributed: 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.
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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. Class II

Reason: Expiration date on the patient label and date on the product carton were not the same.

Medshape Solutions, INC. 20130404 Terminated
Distributed: Nationwide Distribution including the states of CO, FL, GA, IA, MD, MO, OR, TX, VT, VA, and WI.
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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. Class II

Reason: 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.

Cypress Medical Products LLC 20130415 Terminated
Distributed: US Distribution to the state of VA only.
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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. Class II

Reason: 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.

Siemens Healthcare Diagnostics, Inc. 20130306 Terminated
Distributed: US Nationwide Distribution including Puerto Rico.
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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. Class II

Reason: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

Baxter Healthcare Corp. 20130328 Terminated
Distributed: Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
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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. Class II

Reason: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

Baxter Healthcare Corp. 20130328 Terminated
Distributed: Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
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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. Class II

Reason: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

Baxter Healthcare Corp. 20130328 Terminated
Distributed: Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
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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. Class II

Reason: Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

Baxter Healthcare Corp. 20130328 Terminated
Distributed: Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
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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 Class II

Reason: There is a possibility that the Collins Radioparent Sternal Blades Nylon may break during use.

Symmetry Medical/SSI 20130410 Terminated
Distributed: Worldwide Distribution - USA including CA, MS, FL, PA, TN, CO, IL, TX, OH, MI, MA, IL and internationally to Belgium, Canada, Germany, UK
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