RecallRadar

FDA Device recall Z-0972-2020

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

On 2020-02-12 the FDA classified a Class II recall of Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823 by Cook, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0972-2020
ClassificationClass II
Statusterminated
Initiated2019-01-04
Published2020-02-12
Last updated2026-09-13 11:55 UTC
CompanyCook
DistributionUS

Product

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

Reason

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.

Identifiers

code_info
8011030 8033568 8063430 8063431 8150491 8417631 8417632 8587162 8587163 8590532 8590533 7990830 8003084 80…8011030 8033568 8063430 8063431 8150491 8417631 8417632 8587162 8587163 8590532 8590533 7990830 8003084 8033571 8063428 8590520 8590522 8629475 NS8629473

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0972-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.