Z-3226-2017Class II

Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for...

Name: Z-3226-2017 Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for...
Creator: C.R. Bard, Inc.
Published: 2017-07-28
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2017-07-28 / Terminated / root cause: manufacturing process

FDA source

C.R. Bard, Inc. began a recall of Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring... on 2017-07-28. FDA classified it as Class II and gives the reason as "Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3226-2017
Classification: Class II
Status: Terminated
Initiated: 2017-07-28
Posted: 2018-10-11
Terminated: 2020-08-25
Recalling firm: C.R. Bard Inc
Product: Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.
Product code: MJC Catheter, Urological (Antimicrobial) And Accessories
Reason for recall: Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Customers were notified via letter on 07/28/2017. Instructions included to examine their inventory and identify affected product and notify customers if further distributed. Bard Medical Division asks that customers contact customer service at 1-800-526-4455 if any affected units do not meet their needs.
Quantity in commerce: 45,270 units
Distribution: Distribution to AL, AZ, CA, FL, GA, IL, IN, KS, KY, MA, MO, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA.
Product codes and lots: Catalog No. 51514; Lot No. 53623024, 53623054, 53623047, 53623122; Exp Date 01/31/2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3226-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3226-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-27

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)