BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
FDA device recall Z-0022-2009 · posted 2008-10-03 · Terminated
Recall details
- Recalling firm
- Becton Dickinson and Company
- Reason for recall
- Product labeled as 4 mm High Viscosity Injector tip contains a 6 mm tip.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- HMX
- Quantity affected
- 1485 units
- Distribution
- AZ, CA, CO, IL, OH, FL, PA , TN, TX,and VA Foreign: Australia and Japan.
- Date initiated
- 2008-09-15
- Date posted
- 2008-10-03
- Date terminated
- 2012-02-29
- Location
- Waltham, MA
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