CLASS II Device recall · Reported 9 Sep 2015 · FDA Enforcement Report

Magic3 Intermittent Catheter recalled by C.R. Bard

C.R. Bard is recalling Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product, distributed in 14 states. The recall was initiated on 24 Aug 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 53621456
Quantity recalled8,970 each

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2732-2015
FDA event ID
72024
Recalling firm
C.R. Bard, Covington, GA
Classification
Class II
Status
Terminated
Recall initiated
24 Aug 2015
FDA classified
3 Sep 2015
Reported
9 Sep 2015
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

24 Aug 2015Recall initiated by company
3 Sep 2015Classified by FDA+10 days
9 Sep 2015Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential breach of the sterile barrier packaging.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

US Distribution to states of:CA, FL, IL, MA, MN, NH, NJ, NY, NC, OH, OK, PA, TX, and WA.

CaliforniaFloridaIllinoisMassachusettsMinnesotaNorth CarolinaNew HampshireNew JerseyNew YorkOhioOklahomaPennsylvaniaTexasWashington

Questions about this recall

Is Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product recalled?

Yes. C.R. Bard recalled Magic3 Intermittent Catheter with Sure Grip Hydrophilic Coated Silicone Coude tip, Product on 24 Aug 2015. The recall is Class II and its status is Terminated. Recall number Z-2732-2015.

Why was it recalled?

Potential breach of the sterile barrier packaging.

Which lots are affected?

Lot Number 53621456

Where was it sold?

US Distribution to states of:CA, FL, IL, MA, MN, NH, NJ, NY, NC, OH, OK, PA, TX, and WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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