FDA Device recall Z-2537-2021
Catalog A943216, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device
- FDA Device
- Class II
- ongoing
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of Catalog A943216, 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
| Agency | FDA Device |
|---|---|
| Recall number | Z-2537-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-08-05 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | C R Bard |
| Distribution | US |
Product
Catalog A943216, 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 A943216, Lot NGEVX108, UDI (01)00801741100833(17)201228(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-2537-2021%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.