FDA Recall
Terminated
BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Recall: Z-0022-2009
·
Initiated September 15, 2008
Recall
- Recall Number
- Z-0022-2009
- Event Number
- 49436
- Firm
- Becton Dickinson and Company
- FEI Number
- 1211998
- Product Code
- HMX
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- September 15, 2008
- Posted
- October 3, 2008
- Terminated
- February 29, 2012
- Address
- 411 Waverley Oaks Rd, Ste 2229, Waltham, MA, 02452-8448
Description
BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Reason
Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip.
Action
BD contacted accounts by telephone on 9/15/08 requesting users to discard units and complete the response form. Contact Becton Dickinson and Co. at 1-781-906-7950 for assistance.
Distribution
AZ, CA, CO, IL, OH, FL, PA , TN, TX,and VA Foreign: Australia and Japan.
Quantity
1485 units