Catalog A800365, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Check against the official notice below — it lists the full affected range.
C.R. Bard Inc. is recalling 18,060 units of its SureStep Foley Tray with Bard Lubricath Foley Catheter Tray (Catalog A800365) due to potential packaging defects that may compromise the sterile barrier. The affected product was distributed nationwide across five specific lots: NGFR3131, NGFR3295, NGFR4413, NGFR4599, and NGFS3150.
The recall notice does not specify a remedy or instructions 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: 18,060 units Lot/code info: Catalog A800365, Lots: NGFR3131, UDI (01)00801741073960(17)201220(10); NGFR3295, UDI (01)00801741073960(17)201220(10); NGFR4413, UDI (01)00801741073960(17)201220(10); NGFR4599, UDI (01)00801741073960(17)201220(10); and NGFS3150 UDI (01)00801741073960(17)201220(10)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.