PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: September 9, 2015 Initiated: August 24, 2015 #Z-2732-2015

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.

Details

Recalling Firm
C.R. Bard, Inc.
Units Affected
8,970 each
Distribution
US Distribution to states of:CA, FL, IL, MA, MN, NH, NJ, NY, NC, OH, OK, PA, TX, and WA.
Location
Covington, GA

Frequently Asked Questions

What product was recalled?
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. Recalled by C.R. Bard, Inc.. Units affected: 8,970 each.
Why was this product recalled?
Potential breach of the sterile barrier packaging.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 9, 2015. Severity: Moderate. Recall number: Z-2732-2015.