Z-0198-2016Class III

Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units

Name: Z-0198-2016 Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
Creator: C.R. Bard, Inc.
Published: 2015-10-02
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2015-10-02 / Terminated / root cause: labeling and UDI

FDA source

C.R. Bard, Inc. began a recall of Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units on 2015-10-02. FDA classified it as Class III and gives the reason as "Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French". 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-0198-2016
Classification: Class III
Status: Terminated
Initiated: 2015-10-02
Posted: 2015-11-02
Terminated: 2016-08-01
Recalling firm: C.R. Bard Inc
Product: Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units
Product code: MJC Catheter, Urological (Antimicrobial) And Accessories
Reason for recall: Incorrect unit labeling. The case label and shelf box are correct, Product Code 63512 and Catheter Size 12 French. The unit label (catheter package) may state Product Code 63516 and Catheter Size 16 French.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Bard sent a Customer Notification Letter dated September 29 to customers via FedEx with proof of delivery notice. The letter identified the product, the problem, and the action to be taken by the customer. The consignees were instructed to carry out the notification to the user level. Customers with questions were instructed to contact BMD at 1-770-784-6471.
Quantity in commerce: 4,170 each
Distribution: Nationwide Distribution including CA, FL, IL, MO, NJ, OR, PA, TX & WA.
Product codes and lots: Lot 53620131

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0198-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0198-2016	Class III	Terminated	Voluntary: Firm initiated	2015-11-11	2015-11-02

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)