Recall Z-0975-2020— Cook Inc.

Name: FDA recall Z-0975-2020
Creator: U.S. Food and Drug Administration
Published: 2019-01-04

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2019-01-04, terminated 2020-05-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128. 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..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-01-04
Terminated: 2020-05-29
Firm location: Bloomington, IN, United States

Product description

Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.