Recall Z-2386-2015— C.R. Bard, Inc.

Name: FDA recall Z-2386-2015
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 Catheters (6"), 14 Fr, (30/box), Product Code 51614. 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 Catheters (6"), 14 Fr, (30/box), Product Code 51614. 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.