RegWardenFDA facility compliance records
Recall

Class II — C.R. Bard, Inc.

Recalling firmC. R. Bard, Inc.
Registered facilityView this company's 19 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonDuring an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile.
ProductOption-vf Urinary Catheter. Female use only. Latex Free. Sterile, Rx only.
Quantity274 units
DistributionUS Distribution to the states of : AL, CA, CO, FL, IL, IN, MA, MD, NJ, NY, OR, PA, TN, WA, and WI.
Initiated2016-07-11
Classified2016-09-15
Terminated2017-03-22
Recall numberZ-2830-2016
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — C.R. Bard, Inc. (Z-2830-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74712/

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