Z-2732-2015Class II

Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The...

Name: Z-2732-2015 Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The...
Creator: C.R. Bard, Inc.
Published: 2015-08-24
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2015-08-24 / Terminated / root cause: packaging

FDA source

C.R. Bard, Inc. began a recall of Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product Code 50614. The catheters are packaged in film-to-film pouches and... on 2015-08-24. FDA classified it as Class II and gives the reason as "Potential breach of the sterile barrier packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2732-2015
Classification: Class II
Status: Terminated
Initiated: 2015-08-24
Posted: 2015-09-03
Terminated: 2016-08-01
Recalling firm: C.R. Bard Inc
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
Product code: KOD Catheter, Urological
Reason for recall: Potential breach of the sterile barrier packaging.
Root cause tag: packaging
FDA root cause: Unknown/Undetermined by firm
Action: The firm, Bard, sent an "URGENT: MEDICAL PRODUCT RECALL" letter dated August 20, 2015 to customers via FedEx on 8/24/2015. The letter describes the product, problem and actions to be taken. The customers were instructed to not use or further distribute any affected product; check inventory and remove any identified affected product from your shelves; complete and return the Recall and Effectiveness Check Form by September 19, 2015, even if you have used or no longer have possession of the affected product, via fax to 1-770-784-6469 or email a scanned copy to [email protected] ( if you cannot fax or email the form, call 1-770-784-6471 and report the required information verbally); and if you have further distributed any units of the affected lot, identify your customers and notify them at once of this product recall, and return product to Bard Medical Division, 8195 Industrial Blvd., Covington, GA 30014. BMD will provide replacement product or credit for your return product. If you have any questions, please call Vice President, Quality Assurance at 770-784-6119.
Quantity in commerce: 8,970 each
Distribution: US Distribution to states of:CA, FL, IL, MA, MN, NH, NJ, NY, NC, OH, OK, PA, TX, and WA.
Product codes and lots: Lot Number 53621456

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2732-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2732-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-09	2015-09-03

Product code KOD

K000723Class IIHydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic)Rochester Medical Corp. / cleared 2000-05-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)