RecallRadar

FDA Device recall Z-0974-2020

Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151

On 2020-02-12 the FDA classified a Class II recall of Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151 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-0974-2020
ClassificationClass II
Statusterminated
Initiated2019-01-04
Published2020-02-12
Last updated2026-09-13 11:55 UTC
CompanyCook
DistributionUS

Product

Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G14885 G14887 G17151

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_info8011027 8183322 8037660 8030233 8018054 7994816

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-0974-2020%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.