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Open, Classified

Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Number: THSF-35-145-AES-SGH (GPN G06801) THSF-38-80-AES-SGH (GPN G06874)

FDA Recall Z-1824-2022 · Posted 2022-09-28

Recalling FirmCook Incorporated
Recall StatusOpen, Classified
Product CodeDQX
Date Initiated2022-08-16
Product Quantity204 OUS

Reason for Recall

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

Firm Action

On August 16, 2022, Cook Medical notified affected customers of the recall. Customers were instructed to immediately cease all further distribution and use of the affected products. Affected product should be quarantined and returned to Cook Medical to receive product credit. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235

Root Cause

Under Investigation by firm

Distribution Pattern

Domestic distribution nationwide. Foreign distribution worldwide.

Official Source

View FDA Recall →

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

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