Recall Z-0978-2020— Cook Inc.

Name: FDA recall Z-0978-2020
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. It names one FDA 510(k) clearance: K151051. Product: Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703 G53706 G53711 G53723 G53724 G53725 G53726. 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

510(k) clearances named in this recall

1 on FDA's record

K151051 — Universa Soft Ureteral Stents and Stent SetsCook Incorporated·cleared 2016-01-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703 G53706 G53711 G53723 G53724 G53725 G53726

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.