Recall Z-2388-2015— C.R. Bard, Inc.

Name: FDA recall Z-2388-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-07

Class II · Terminated

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2015-07-07, terminated 2017-07-21. It names one FDA 510(k) clearance: K000723. Product: Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.. Reason: Potential breach of the sterile barrier packaging..

Recalling firm: C.R. Bard, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-07-07
Terminated: 2017-07-21
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K000723 — HYDROPHILIC SILICONE FOLEY CATHETER AND PERSONAL CATHETER (HYDROPHILIC AND NON-HYDROPHILIC)Rochester Medical Corp.·cleared 2000-05-19

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

Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.

Reason for recall

Potential breach of the sterile barrier packaging.

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