FDA Recall
Terminated
BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618
Recall: Z-0672-2007
·
Initiated March 2, 2007
Recall
- Recall Number
- Z-0672-2007
- Event Number
- 37533
- Firm
- Becton Dickinson and Company
- FEI Number
- 1211998
- Product Code
- KYG
- Status
- Terminated
- Root Cause
- Other
- Initiated
- March 2, 2007
- Posted
- March 29, 2007
- Terminated
- March 5, 2008
- Address
- 411 Waverley Oaks Rd, Ste 2229, Waltham, MA, 02452-8448
Description
BD Visitec Irrigating Cytosome, for use in cataract surgery. Ref 581618
Reason
Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm)
Action
BD Opthalmic notifiied accounts by telephone on 3/2/07 and followed with letter. Accounts are requested to return product.
Distribution
Nationwide.
Quantity
1500 units