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Terminated

Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413.

FDA Recall Z-1162-2007 · Posted 2007-08-09

Recalling FirmCook Urological, Inc.
Recall StatusTerminated
Product CodeEZB
Date Initiated2007-06-12
Date Terminated2009-11-25
Product Quantity100

Reason for Recall

Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.

Firm Action

Consignees were notified via letter dated 6/12/07 and instructed to cease using the product and to inform the firm if they have product to return.

Root Cause

Process control

Distribution Pattern

Nationwide and Canada.

Official Source

View FDA Recall →

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

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