Z-0600-2017Class II

Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile

Name: Z-0600-2017 Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile
Creator: C.R. Bard, Inc.
Published: 2016-10-05
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2016-10-05 / Terminated / root cause: labeling and UDI

FDA source

C.R. Bard, Inc. began a recall of Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile Product Usage: The catheter is an all silicone, single lumen, drainage... on 2016-10-05. FDA classified it as Class II and gives the reason as "Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0600-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-05
Posted: 2016-11-17
Terminated: 2021-10-08
Recalling firm: C.R. Bard Inc
Product: 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.
Product code: MJC Catheter, Urological (Antimicrobial) And Accessories
Reason for recall: Misbranding; the product labeled as an Antibacterial Hydrophilic Intermittent Catheter, is instead an Antibacterial Intermittent Catheter (no Hydrophilic Coating).
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Bard Medical sent an Urgent Medical Device Product Recall letter dated October 5, 2016 to customers The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine and quarantine and return affected inventory. Customers were asked to complete and return the accompanying Recall & Effectiveness Check Form attached.
Quantity in commerce: 10,290 units
Distribution: US Nationwide Distribution in the states of: CA, FL, IL, IN, MN, MO, NC, NJ, NY, OH, OK, PA, TX and UT.
Product codes and lots: Product Code: 53514, Lot number: 53622813, Exp. Date: 30Sep2017.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0600-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0600-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16

Product code MJC

K033477Class IIHydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System KitRochester Medical Corp. / cleared 2004-06-10

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)