Z-1437-2012

ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x...

Name: Z-1437-2012 ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x...
Creator: Teva Pharmaceuticals USA, Inc.
Published: 2012-03-30
License: https://open.fda.gov/license/

Teva Pharmaceuticals USA, Inc. / initiated 2012-03-30 / Terminated / root cause: manufacturing process

FDA source

Teva Pharmaceuticals USA, Inc. began a recall of ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags). Disposable kidney perfusion set on 2012-03-30. The reason FDA records is "Lack of assurance of sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1437-2012
Status: Terminated
Initiated: 2012-03-30
Posted: 2012-04-18
Terminated: 2012-10-25
Recalling firm: Teva Pharmaceuticals USA, Inc.
Product: ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags). Disposable kidney perfusion set.
Product code: KDL Set, Perfusion, Kidney, Disposable
Reason for recall: Lack of assurance of sterility
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Product code 1000-46-06, lot # 16EK007, exp 10/2012; and 16EK0193, exp 10/2012

Product code KDL

K944866Class IIViaspan (Belzer Uw - Css)The Dupont Merck Pharmaceutical Co. / cleared 1996-04-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)