Catalog A800361, SureStep" Foley Tray, Bard LubricathTM Foley Catheter Tray
Check against the official notice below — it lists the full affected range.
C.R. Bard Inc. has recalled approximately 33,380 units of its SureStep Foley Tray with Bard Lubricath Foley Catheter Tray (Catalog A800361) due to potential packaging defects that may compromise the sterile barrier. The affected product was distributed nationwide and includes seven specific lot numbers: NGFR0310, NGFR0311, GFR2807, NGFR2829, NGFR3571, NGFR5475, and NGFR5481. If packaging is defective, the sterile contents may no longer be safe to use.
The recall record does not specify what affected consumers should do regarding 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: 33,380 units Lot/code info: 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)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.