—#170632

Product

Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823

FDA product code: GBL — Catheter, Ureteral, General & Plastic Surgery
Device class: Class N
Medical specialty: Gastroenterology, Urology
Affected lot / code info: 8011030 8033568 8063430 8063431 8150491 8417631 8417632 8587162 8587163 8590532 8590533 7990830 8003084 8033571 8063428 8590520 8590522 8629475 NS8629473

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 #170632. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.