Catalog A303316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Urine Meter, StatLock" Stabilization Device
Check against the official notice below — it lists the full affected range.
C.R. Bard Inc. is recalling 11,600 units of its SureStep Foley Tray (Catalog A303316A) due to potential packaging defects that may compromise the sterile barrier. The product was distributed nationwide. The affected lots are NGEVX103 (expiration 08/31/2022), NGFR3290 (expiration 02/28/2023), NGFR3291 (expiration 02/28/2023), and NGFR4542 (expiration 02/28/2023).
The recall notice does not specify a remedy or recommended action for consumers who have this product.
Written by software from the official notice below. Not reviewed by a lawyer.
There is potential for packaging defects that may impact the sterile barrier.
Reason for recall: There is potential for packaging defects that may impact the sterile barrier. Distribution: US Nationwide distribution. Quantity: 11,600 units Lot/code info: Catalog A303316A, Lots: NGEVX103 (exp. 08/31/2022), UDI (01)00801741073793(17)201220(10); NGFR3290 (02/28/2023), UDI (01)00801741073793(17)201220(10); NGFR3291 (exp. 02/28/2023), UDI (01)00801741073793(17)201220(10); and NGFR4542 (exp. 02/28/2023) UDI (01)00801741073793(17)201220(10)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.