MicroSTAAR Injector w/ Foam Tip Plunger, Model MSI-PF
FDA Recall Z-0766-04 · Posted 2004-07-20
Recalling FirmStaar Surgical Co Inc
Recall StatusTerminated
Product CodeKYB
Date Initiated2004-02-23
Date Terminated2005-01-04
Product Quantity690 injectors
Reason for Recall
Injector mold design/manufacture and wear caused material flash to develop preventing assembly of the device prior to use.
Firm Action
Firm will be sending thier representatives to customers to inspect inventory and arrange return of product.
Root Cause
Other
Distribution Pattern
Nationwide.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.