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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
StatusOngoing
ReasonThere is potential for packaging defects that may impact the sterile barrier.
ProductCatalog A902416, SureStep" Foley Tray, Silicone, Urine Meter, StatLock" Stabilization Device
Quantity4830 units
DistributionUS Nationwide distribution.
Initiated2021-08-05
Classified2021-09-23
Recall numberZ-2539-2021
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-2539-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88499/

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