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Open, Classified

Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-ROSEN G01623 THSCF-35-80-1.5-ROSEN G01774 THSCF-35-180-1.5-ROSEN G01264 THSCF-35-145-1.5-ROSEN G01261

FDA Recall Z-1842-2022 · Posted 2022-09-28

Recalling FirmCook Incorporated
Recall StatusOpen, Classified
Product CodeDQX
Date Initiated2022-08-16
Product Quantity5041 US; 298 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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K171764Fixed Core Wire GuidesCook Incorporated · 2018-03-09

Official Source

View FDA Recall →

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

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