FDA Recall
Terminated
MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF
Recall: Z-0766-04
·
Initiated February 23, 2004
Recall
- Recall Number
- Z-0766-04
- Event Number
- 28570
- Firm
- Staar Surgical Co Inc
- FEI Number
- 2023826
- Product Code
- KYB
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 23, 2004
- Posted
- July 20, 2004
- Terminated
- January 4, 2005
- Address
- 1911 Walker Ave, Monrovia, CA, 91016-4846
Description
MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF
Reason
Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use.
Action
Firm will be sending thier representatives to customers to inspect inventory and arrange return of product.
Distribution
Nationwide.
Quantity
690 injectors