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Terminated

Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number (REF) 133724.

FDA Recall Z-1168-2007 · Posted None

Recalling FirmVance Products Incorporated
Recall StatusTerminated
Product CodeFAD
Date Initiated2007-06-29
Date Terminated2008-06-11
Product Quantity75

Reason for Recall

The radiographic band may detach from the stent and remain in the patient after removal of the stent.

Firm Action

Consignees were notified of the recall via letter dated 6//29/07, which instructed them to quarantine stock on hand and to fax number on hand back to Cook for return authorization.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Canada, and Japan.

Official Source

View FDA Recall →

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

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