ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags). Disposable kidney perfusion set.
FDA Recall Z-1437-2012 · Posted 2012-04-18
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Recalling FirmTeva Pharmaceuticals USA, Inc.
Recall StatusTerminated
Product CodeKDL
Date Initiated2012-03-30
Date Terminated2012-10-25
Product Quantity4,070
Reason for Recall
Lack of assurance of sterility
Firm Action
Teva Pharmaceuticals USA sent an "URGENT MEDICAL DEVICE RECALL-RETAIL LEVEL" letter dated March 30, 2012. The letter identifies the problem, product, and actions to be taken by the customers. The letter instructs customers to check their inventory and to discontinue distribution of the affected product. A Stock Response Form was enclosed for customers to complete and return via fax to 817-868-5362. Contact Teva Customer Services at 800-545-8800 for questions regarding this notice.
Root Cause
Material/Component Contamination
Distribution Pattern
Nationwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CT, DE, FL, GA, IA, IL, KS, KY, LA, MA, MD, MN, MO, NC, ND, NE, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV and Washington, D.C.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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