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Terminated

Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL.

FDA Recall Z-0377-2007 · Posted 2007-01-25

Recalling FirmCook Urological, Inc.
Recall StatusTerminated
Product CodeFED
Date Initiated2007-01-05
Date Terminated2008-05-01
Product Quantity4

Reason for Recall

Lack of assurance of sterility, as the packages may not have been sealed.

Firm Action

Consignees were notified via recall letter dated 1/5/07 and requested to return the product.

Root Cause

Other

Distribution Pattern

Massachusetts, Maine, New Hampshire and Puerto Rico.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043418COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTHCook Urological, Inc. · 2005-03-31

Official Source

View FDA Recall →

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

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