RegWardenFDA facility compliance records
Recall

Class III — 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 III
StatusTerminated
ReasonLabeling problem
ProductSureStep Tray, with Add-a-Foley, COMPLETE CARE, Drainage Bag, and STATLOCK Stabilization The product is a urine collection system that includes a STATLOCK Foley Stabilization Device
Quantity530 units
DistributionNationwide Distribution to CA, FL, IL, IA, KY, NC, MN, NC, OR, RI, SD, TX, UT, and WA.
Initiated2016-06-29
Classified2016-08-03
Terminated2017-12-05
Recall numberZ-2333-2016
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 III recall — C.R. Bard, Inc. (Z-2333-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/74610/

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