Z-2388-2015Class II

Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product...

Name: Z-2388-2015 Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product...
Creator: C.R. Bard, Inc.
Published: 2015-07-07
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2015-07-07 / Terminated / root cause: packaging

FDA source

C.R. Bard, Inc. began a recall of Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter on 2015-07-07. FDA classified it as Class II and gives the reason as "Potential breach of the sterile barrier packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2388-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-07
Posted: 2015-08-14
Terminated: 2017-07-21
Recalling firm: C.R. Bard Inc
Product: Magic3 Hydrophilic-coated Female Intermittent Urinary Catheter 14 Fr in the Insertion Supply Kit, Product Code 51614S. Intermittent catheter.
Product code: KOD Catheter, Urological
Reason for recall: Potential breach of the sterile barrier packaging.
Root cause tag: packaging
FDA root cause: Unknown/Undetermined by firm
Action: A recall notice was sent to consignees on 7/7/2015 asking them to discontinue use of the product. The letter to the distributors requested a sub-recall. Both letters included a response form to be returned to Bard.
Quantity in commerce: 534,972 each
Distribution: Nationwide Distribution-including AL, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NV, NH, NJ, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI AND DC.
Product codes and lots: Lot Number 53620387, 53621274, 53621279

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2388-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2384-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-14
Z-2385-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-14
Z-2386-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-14
Z-2387-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-14
Z-2388-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-26	2015-08-14

Product code KOD

K000723Class IIHydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and Non-Hydrophilic)Rochester Medical Corp. / cleared 2000-05-19

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)