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Terminated

GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE

FDA Recall Z-0860-03 · Posted 2003-05-22

Recalling FirmMedegen Medical Products, LLC
Recall StatusTerminated
Product CodeKCP
Date Initiated2003-04-30
Date Terminated2003-11-14

Reason for Recall

Finished products were not sterilized.

Firm Action

Medegen has notified all direct accounts by certified mail on 4/30/03.

Root Cause

Other

Distribution Pattern

Nationwide domestic distribution. Foreign distribution to Canada and Saudia Arabia. No government and military consignees.

Official Source

View FDA Recall →

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

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