Recalls / —
—#170633
Product
C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
- FDA product code
- FAD — Stent, Ureteral
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- Affected lot / code info
- NS7953136 NS8169661 NS8180857 NS8169662 NS8180858 NS8180859 NS8180860
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 #170633. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.