Catalog A300316A, SureStep" Foley Tray, Bardex" I.C., Complete Care", Drainage Bag, StatLock" Stabilization Device
Check against the official notice below — it lists the full affected range.
C.R. Bard Inc. is recalling 11,780 units of its SureStep Foley Tray catalog A300316A, which includes a Bardex I.C. catheter, Complete Care drainage bag, and StatLock stabilization device. The recall affects products distributed nationwide in the United States across four specific lots with expiration dates between February 28, 2023 and August 31, 2022. The company identified potential packaging defects that may compromise the sterile barrier of the product.
The recall source does not specify a remedy or recommended action for affected consumers.
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: 11,780 units Lot/code info: Catalog A300316A, Lots: NGEVX104 (exp. 08/31/2022), UDI (01)00801741073731(17)201228(10); NGFR3628 (02/28/2023), UDI (01)00801741073731(17)201228(10); GFS1114 (02/28/2023), UDI (01)00801741073731(17)201228(10); and NGFS1166 (02/28/2023), UDI (01)00801741073731(17)201228(10)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.