FDA Recall
Terminated
Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399
Recall: Z-0094-2011
·
Initiated July 16, 2010
Recall
- Recall Number
- Z-0094-2011
- Event Number
- 56279
- Firm
- Codman & Shurtleff, Inc.
- FEI Number
- 3002947440
- Product Code
- HBA
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- July 16, 2010
- Posted
- October 20, 2010
- Terminated
- July 9, 2012
- Address
- 325 Paramount Drive, Raynham, MA, 02767
Description
Codman 1/4 x 1/4" Surgical Patties (20 pouches of 10 patties per box) Product code: 80-1399
Reason
Surgical Pattie x-ray stripe (radio-opaque marker) became detached
Action
Codman notified customers by letter dated 7/16/10 issued July 23 through July 26, 2010 via Fed'x overnight advising users that the x-ray marker on Codman Surgical Patties may become detached. Customers are instructed to return product from affected lots. An error in the original letter was discovered and a corrected letter dated July 28, 2010 issued. If there are any questions, please contact Codman at (800) 225-0460.
Distribution
Nationwide Foreign: Canada, Singapore, Belgium, Mexico, Madrid, Dubai, Tokyo, Brazil, New Zealand, Egypt, South Africa, Singapore,
Quantity
4407 boxes (20 pouches of 10 patties)