Recall Z-2064-2018— C.R. Bard, Inc.

Name: FDA recall Z-2064-2018
Creator: U.S. Food and Drug Administration
Published: 2017-12-13

Class II · Terminated

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2017-12-13, terminated 2020-12-14. It names one FDA 510(k) clearance: K910195. Product: Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522). Reason: Foley Catheter with Incorrect Retainer Cap Print.

Recalling firm: C.R. Bard, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-12-13
Terminated: 2020-12-14
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K910195 — BARD HYDROGEL-COATED FOLEY CATHETERSC.R. Bard, Inc.·cleared 1991-08-09

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

Bardex Lubricath 3-Way 75cc Continuous Irrigation Foley Catheter (Creevy), 22Fr. Rx (01267522)

Reason for recall

Foley Catheter with Incorrect Retainer Cap Print

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