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Terminated

Cook brand Embolization Coils, stainless steel, sterile, 20 MM diameter, .038'' (0.97 mm) diameter embolus, 20 MM diameter, 20 MM long For use with .038'' end hole; Reorder # MWCE-38-20-20.

FDA Recall Z-0368-06 · Posted 2006-01-10

Recalling FirmCook, Inc.
Recall StatusTerminated
Product CodeKRD
Date Initiated2005-09-26
Date Terminated2006-01-10
Product Quantity242

Reason for Recall

The coil is 20 centimeters in length, but the label states the length is 20 millimeters.

Firm Action

Consignees were notified via telephone and recall letter dated September 26, 2005.

Root Cause

Other

Distribution Pattern

Delaware, New York and Pennsylvania.

Official Source

View FDA Recall →

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

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