C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
Reported: February 12, 2020 Initiated: January 4, 2019 #Z-0973-2020
Product Description
C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367
Reason for Recall
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.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 13388 total
- Distribution
- 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.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14367. Recalled by Cook Inc.. Units affected: 13388 total.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2020. Severity: Moderate. Recall number: Z-0973-2020.
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