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Terminated

TLC Self -Retaining Retractor System-5/box Product Number:820-176

FDA Recall Z-0258-06 · Posted 2005-12-01

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeGAD
Date Initiated2005-10-25
Date Terminated2007-06-20
Product Quantity1416

Reason for Recall

Sterility of device compromised due to breach in packaging

Firm Action

Boston Scientific initiated the recall on October 25, 2005 to accouunts requesting the return of the product and completion of the Reply Verification Tracking Form.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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