Recall Z-0967-2020— Cook Inc.

Name: FDA recall Z-0967-2020
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: K833762. Product: Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649. 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

K833762 — PERCUTANEOUS RETROGRADE NEPHROSTOMYVpi·cleared 1984-02-10

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

Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649

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.