RecallRadar

FDA Device recall Z-2531-2021

Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

On 2021-09-29 the FDA classified a Class II recall of Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray 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-2531-2021
ClassificationClass II
Statusongoing
Initiated2021-08-05
Published2021-09-29
Last updated2026-09-13 11:56 UTC
CompanyC R Bard
DistributionUS

Product

Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray

Reason

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

Identifiers

code_info
Catalog A800361, Lots: NGFR0310, UDI (01)00801741073939(17)201220(10); NGFR0311,UDI N(01)00801741073939(17)201220(10);…Catalog A800361, Lots: NGFR0310, UDI (01)00801741073939(17)201220(10); NGFR0311,UDI N(01)00801741073939(17)201220(10); GFR2807, UDI (01)00801741073939(17)201220(10); NGFR2829, UDI (01)00801741073939(17)201220(10); NGFR3571, UDI (01)00801741073939(17)201220(10); NGFR5475, UDI (01)00801741073939(17)201220(10); nd NGFR5481 UDI (01)00801741073939(17)201220(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-2531-2021%22

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