Recall Z-1870-2017— Cook Inc.

Name: FDA recall Z-1870-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-07

Class II · Terminated

Class II FDA medical device recall by Cook Inc., initiated 2017-03-07, terminated 2018-10-16. It names one FDA 510(k) clearance: K923436. Product: Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set. Reason: Product may overheat, melt, and burn patient..

Recalling firm: Cook Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-03-07
Terminated: 2018-10-16
Firm location: Bloomington, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K923436 — ILLUMINATED URETERAL CATHETERCook Urological, Inc.·cleared 1993-03-05

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

Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set

Reason for recall

Product may overheat, melt, and burn patient.

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