Recall Z-2831-2016— C.R. Bard, Inc.

Name: FDA recall Z-2831-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-11

Class II · Terminated

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2016-07-11, terminated 2017-03-22. It names one FDA 510(k) clearance: K041983. Product: Option-vm Urinary Catheter. Male use only. Latex Free. Sterile, Rx only.. Reason: During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile..

Recalling firm: C.R. Bard, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-07-11
Terminated: 2017-03-22
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K041983 — OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016Opticon Medical·cleared 2004-11-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.

Data sourced from openFDA. This site is unofficial and independent of the FDA.