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FDA (Device enforcement)Recalled 2021-08-05class ii

C.R. Bard Inc: Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

Is my product affected?

Catalog A902916, SureStep" Foley Tray, Lubricath", Urine Meter, StatLock" Stabilization Device

  • UPC 00801741074073

Check against the official notice below — it lists the full affected range.

What happened

C.R. Bard Inc. is recalling approximately 29,890 units of its SureStep Foley Tray (Catalog A902916) that were distributed nationwide. The recall was issued due to potential packaging defects that may compromise the sterile barrier of the product. The affected units are identified by six specific lot numbers: NGFR3115, NGFR3278, NGFR3279, NGFS1308, NGFS1309, and NGFS1366, all with an expiration date of December 28, 2025.

The recall notice does not specify a remedy or recommended course of action for consumers who may have this product.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There is potential for packaging defects that may impact the sterile barrier.

Details from the source

Reason for recall: There is potential for packaging defects that may impact the sterile barrier. Distribution: US Nationwide distribution. Quantity: 29,890 units Lot/code info: Catalog A902916, Lots: NGFR3115, UDI (01)00801741074073(17)251228(10); NGFR3278, UDI (01)00801741074073(17)251228(10); NGFR3279, UDI (01)00801741074073(17)251228(10); NGFS1308, UDI (01)00801741074073(17)251228(10); NGFS1309, UDI (01)00801741074073(17)251228(10); and NGFS1366, UDI (01)00801741074073(17)251228(10)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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