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U.S. Department of Health and Human Services

Class 2 Device Recall ViaSpan Cold Storage Solution 1000mL Bag

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  Class 2 Device Recall ViaSpan Cold Storage Solution 1000mL Bag see related information
Date Initiated by Firm March 30, 2012
Date Posted April 18, 2012
Recall Status1 Terminated 3 on October 25, 2012
Recall Number Z-1437-2012
Recall Event ID 61622
510(K)Number K944866  
Product Classification Set, perfusion, kidney, disposable - Product Code KDL
Product ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags).

Disposable kidney perfusion set.
Code Information Product code 1000-46-06, lot # 16EK007, exp 10/2012; and 16EK0193, exp 10/2012
Recalling Firm/
Teva Pharmaceuticals USA, Inc.
650 Cathill Rd
Sellersville PA 18960-1512
For Additional Information Contact Christopher J. Unger
Manufacturer Reason
for Recall
Lack of assurance of sterility
FDA Determined
Cause 2
Material/Component Contamination
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.
Quantity in Commerce 4,070
Distribution 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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDL and Original Applicant = THE DUPONT MERCK PHARMACEUTICAL CO.