FDA Medical Device Recalls (openFDA)
Teva Pharmaceuticals USA, Inc.: ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags). Disposable kidney perfusion set.
- Recall number
- Z-1437-2012
- 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.
- Status
- Terminated
- Initiated
- 2012-03-30
- Posted
- 2012-04-18
- Terminated
- 2012-10-25
- Reason
- Lack of assurance of sterility
- 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
- 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.
- Lot, serial or model codes
- Product code 1000-46-06, lot # 16EK007, exp 10/2012; and 16EK0193, exp 10/2012
- 510(k) numbers
- ["K944866"]
- PMA numbers
- not on file
- Product code
- KDL
- Firm FEI
- 2517175
- Firm city
- Sellersville
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28