RecallRadar

FDA Device recall Z-2536-2021

Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

On 2021-09-29 the FDA classified a Class II recall of Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device by C R Bard, citing there is potential for packaging defects that may impact the sterile barrier.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2536-2021
ClassificationClass II
Statusongoing
Initiated2021-08-05
Published2021-09-29
Last updated2026-09-13 11:56 UTC
CompanyC R Bard
DistributionUS

Product

Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

Reason

There is potential for packaging defects that may impact the sterile barrier.

Identifiers

code_info
Catalog A902916, Lots: NGFR3115, UDI (01)00801741074073(17)251228(10); NGFR3278, UDI (01)00801741074073(17)251228(10);…Catalog A902916, Lots: NGFR3115, UDI (01)00801741074073(17)251228(10); NGFR3278, UDI (01)00801741074073(17)251228(10); NGFR3279, UDI (01)00801741074073(17)251228(10); NGFS1308, UDI (01)00801741074073(17)251228(10); NGFS1309, UDI (01)00801741074073(17)251228(10); and NGFS1366, UDI (01)00801741074073(17)251228(10)

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2536-2021%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.