Recall Z-2732-2015— C.R. Bard, Inc.

Name: FDA recall Z-2732-2015
Creator: U.S. Food and Drug Administration
Published: 2015-08-24

Class II · Terminated

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2015-08-24, terminated 2016-08-01. It names one FDA 510(k) clearance: K000723. Product: Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter. Reason: Potential breach of the sterile barrier packaging..

Recalling firm: C.R. Bard, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-08-24
Terminated: 2016-08-01
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 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and packaged 30 per box. Used as an Intermittent Urinary Catheter

Reason for recall

Potential breach of the sterile barrier packaging.

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