Z-2831-2016Class II

Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only

Name: Z-2831-2016 Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only
Creator: C.R. Bard, Inc.
Published: 2016-07-11
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2016-07-11 / Terminated / root cause: design

FDA source

C.R. Bard, Inc. began a recall of Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only on 2016-07-11. FDA classified it as Class II and gives the reason as "During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2831-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-11
Posted: 2016-09-15
Terminated: 2017-03-22
Recalling firm: C.R. Bard Inc
Product: Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.
Product code: EZL Catheter, Retention Type, Balloon
Reason for recall: During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
Root cause tag: design
FDA root cause: Device Design
Action: C.R. Bard sent an Urgent - Medical Device Product Recall letter dated July 8, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm notifies customers of the recall, provides a clinical risk statement, and gives instructions regarding product disposition. Facilities are instructed to examine their inventory and quarantine any recalled product. The firm requested that customers complete the Recall & Effectiveness Check Form if product is or is not in inventory. If product was further distributed, customers should be forwarded the recall notification letter and Recall& Effectiveness Check Form. If you or the patient using these catheters has had an adverse event related to the recalled catheters, please contact Bard Medical Division Field Assurance at 1-800-526-4455 (option 5, then option 4) or via email at BMD.FieldAssurance@crbard. com.
Quantity in commerce: 274 units
Distribution: US Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI.
Product codes and lots: Device Listing No.: D022515. CatalogNo.: MV39016. Lot No.: P1007642, P1007465, P1007466, P1007643, P1007641, P1007640, P1007468, P1007467. Exp Date: 08/01/2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2831-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2830-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15
Z-2831-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-21	2016-09-15

Product code EZL

K041983Class IIOption-Vm Urinary Catheter/adpater, Models Mv39016, Mva39016Opticon Medical / cleared 2004-11-17

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)