Cook Inc. Recalls Bander Ureteral Diversion Open-End Stent Sets
Cook Inc. is recalling Bander Ureteral Diversion Open-End Stent Sets because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product where the stiff tip of a medical device could be introduced into a patient, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Cook Inc. is recalling the Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 and G14823. The recall involves 13,388 total units. The product was distributed domestically to the United States and internationally to numerous countries including Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom.
The recall is due to a defect where the wire guide may be incorrectly loaded into the wire guide holder. This error can lead to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip, posing a risk of injury during use.
Healthcare providers and facilities that have received these products should stop using them and contact Cook Inc. for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
- Manufacturer
- Cook Inc.
- Affected units
- 13,388
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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