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Terminated

Gold Hub Monty Infiltration Cannula, Catalog Nos. IC14HM20; IC16HM15; IC18HM15; IC14HM20; IC16HM15; IC18HM15.

FDA Recall Z-0900-05 · Posted 2005-06-17

Recalling FirmHK Surgical Inc
Recall StatusTerminated
Product CodeFIE
Date Initiated2004-12-03
Date Terminated2012-04-19
Product QuantityTo be determined

Reason for Recall

Risk of hubs becoming disconnected from the cannula.

Firm Action

Recall letters were sent 12/3/2004, 04/11-14/2005 letters request return of the cannulas.

Root Cause

Other

Distribution Pattern

Nationwide, Saudi Arabia, New Zealand, Phillipines, Switzerland, Canada, Netherlands, Taiwan, Germany, Japan, Malaysia, United Kingdom, Indonesia, Austria, Belgium, Puerto Rico, England.

Official Source

View FDA Recall →

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

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