Catalog A319516AM, SureStep" Foley Tray, Lubri-Sil" I.C., Temperature Sensing 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 approximately 8,170 units of its SureStep Foley Tray with Lubri-Sil I.C., Temperature Sensing Complete Care, Drainage Bag, and StatLock Stabilization Device (Catalog A319516AM) that were distributed nationwide. The recall was issued because the product packaging may have defects that could compromise the sterile barrier.
The affected units include Lot NGFS1691, NGFR3282, and NGFR4423, each with corresponding UDI codes and an expiration date of December 28, 2020. The recall was expanded on October 8, 2021 to include Lot NGFS1691. The source does not specify a remedy or instructions for what affected consumers should do.
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: 8170 units Lot/code info: Catalog A319516AM, Lot NGFS1691, UDI (01)00801741073892(17)201228(10); NGFR3282, UDI (01)00801741073892(17)201228(10); and NGFR4423, UDI (01)00801741073892(17)201228(10) Expanded 10/8/2021 adding Lot NGFS1691 UDI (01)00801741073892(17)201228(10)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.