CLASS II Device recall · Reported 23 Nov 2016 · FDA Enforcement Report

Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male recalled

C.R. Bard is recalling Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male, distributed nationwide in the US. The recall was initiated on 5 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: 53514, Lot number: 53622813, Exp. Date: 30Sep2017.

Quantity recalled10,290 units

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-0600-2017
FDA event ID: 75365
Recalling firm: C.R. Bard, Covington, GA
Classification: Class II
Status: Terminated
Recall initiated: 5 Oct 2016
FDA classified: 16 Nov 2016
Reported: 23 Nov 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Heart & Vascular Devices

Timeline

5 Oct 2016	Recall initiated by company
16 Nov 2016	Classified by FDA	+42 days
23 Nov 2016	Published in enforcement report	+7 days

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

Reason for recall

Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).

Product as listed by the FDA

Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile Product Usage: The catheter is an all silicone, single lumen, drainage tube with drainage eyes at the proximal end and a tapered funnel at the distal end. The outer surface of the catheter has an antibacterial and hydrophilic coating which binds water molecules to the surface creating a smooth lubricating film. It is packaged with a water sachet that is manually burst to hydrate the catheter coating at time of use. The catheters are packaged in a film-to-film pouch and are sterilized by electron beam irradiation and are distributed as a single use device. The catheter is intended for urinary bladder drainage in adult males and females requiring catheterization for management of incontinence, voiding dysfunction and surgical procedures. Efficacy of the catheter in preventing urinary tract infection during intermittent use has not been established. The device is not intended to be used as a treatment for active urinary tract infection. For urological use only; urinary catheters are intended for use for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.

Where it was distributed

US Nationwide Distribution in the states of: CA, FL, IL, IN, MN, MO, NC, NJ, NY, OH, OK, PA, TX and UT.

Nationwide California Florida Illinois Indiana Minnesota Missouri North Carolina New Jersey New York Ohio Oklahoma Pennsylvania Texas Utah

Questions about this recall

Why was it recalled?

Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).

Which lots are affected?

Product Code: 53514, Lot number: 53622813, Exp. Date: 30Sep2017.

Where was it sold?

US Nationwide Distribution in the states of: CA, FL, IL, IN, MN, MO, NC, NJ, NY, OH, OK, PA, TX and UT.

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 26 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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