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Terminated

COOK Stiffened Micropuncture Introducer Set, 5 FR. Product Reorder Number: MPIS-501-10.0-SC-NT

FDA Recall Z-0432-03 · Posted 2003-02-28

Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeDYB
Date Initiated2002-11-25
Date Terminated2003-03-21
Product Quantity6,872

Reason for Recall

The tip of the stiffened cannula might break during use and remain in the patient.

Firm Action

Recall letters were sent to each customer on November 26, 2002 advising them of the recall and to return stocks on hand.

Root Cause

Other

Distribution Pattern

United States, Brazil, Canada, Dominican Republic and Israel.

Official Source

View FDA Recall →

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

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