—#170591

Product

PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10

FDA product code: OCY — Endoscopic Guidewire, Gastroenterology-Urology
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K082536
Affected lot / code info: 7832498 7832499 7832500 7925385 7925387 7930517 8090868 8287793 8287794 8287799 8400121 8548813 8548815 NS8548814 7760235 7881599 8062433 8074027 8290383 8290384 8404559 8404562 7999663 8077582 8077583 8065959 8073949 8074014 8074015

Why it was recalled

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Root cause (FDA determination)

Process control

Action the firm took

On January 4, 2019, the firm distributed Urgent Medical Device Recall letters to customers via courier mail. Customers were informed that affected lots may contain a wire guide that was incorrectly loaded into the wire guide holder.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, and the United Kingdom.

Timeline

Recall initiated: 2019-01-04
Terminated: 2020-05-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #170591. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.