RecallRadar

FDA Device recall Z-2830-2016

Option-vf Urinary Catheter

On 2016-09-21 the FDA classified a Class II recall of Option-vf Urinary Catheter by C R Bard, citing during an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2830-2016
ClassificationClass II
Statusterminated
Initiated2016-07-11
Published2016-09-21
Last updated2026-09-13 11:54 UTC
CompanyC R Bard
DistributionAL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, WI

Product

Option-vf Urinary Catheter. Female 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.

Identifiers

code_infoDevice Listing No.: D022512. CatalogNo.: FV14218. Lot No.: P1007637, P1007638, P1007461. Exp Date: 08/01/2016.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2830-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.