RecallRadar

FDA Device recall Z-0976-2020

Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951 G17852

On 2020-02-12 the FDA classified a Class II recall of Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951 G17852 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-0976-2020
ClassificationClass II
Statusterminated
Initiated2019-01-04
Published2020-02-12
Last updated2026-09-13 11:55 UTC
CompanyCook
DistributionUS

Product

Sof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951 G17852

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_info8011038 NS7998389 NS8008388 NS8018651 NS8030247 NS8037667 7990842 8599605 8625597 8625598 8172131 8172132 8193001

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-0976-2020%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.