FDAClass IIFebruary 12, 2020

Bander Ureteral Diversion Open-End Stent Set recall

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

Why was Bander Ureteral Diversion Open-End Stent Set 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

8011030 8033568 8063430 8063431 8150491 8417631 8417632 8587162 8587163 8590532 8590533 7990830 8003084 8033571 8063428 8590520 8590522 8629475 NS8629473

Product
Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
Recalling firm
Cook Inc.
Quantity
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.
Recall date
February 12, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls