Cook Inc.: Medical Device Recall in 2020 - (Recall #: Z-0972-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: January 4, 2019
Date Posted: February 12, 2020
Recall Number: Z-0972-2020
Event ID: 82026
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.

Status: Terminated
Product Quantity: 13388 total
Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated