C.R. Bard Inc: BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C

Is my product affected?

BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C

• UPC 00801741183249

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

What happened

C.R. Bard Inc. has recalled 1,620 units of the BARD SURESTEP Intermittent Catheter Tray, 14Fr (REF INTS16C) distributed nationwide across 18 states including Georgia, Maine, New Jersey, Wisconsin, Minnesota, South Dakota, Colorado, North Dakota, Idaho, Illinois, Florida, Louisiana, Maryland, Pennsylvania, Ohio, and Nebraska. The recalled product has a potential to leak where the catheter connects to the drain bag.

The specific affected units are identified by Serial Numbers/UDIs: NGEWX117, NGEXX133, NGEY0842, and NGEZ1823, all with UDI (01)00801741183249(17). The source document does not specify a remedy or recommended action for consumers who possess this product.

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

Hazard

There is a potential to leak from the catheter where it connects to the drain bag

Details from the source

Reason for recall: There is a potential to leak from the catheter where it connects to the drain bag Distribution: US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE. Quantity: 1620 units Lot/code info: Serial Number/UDI NGEWX117 (01)00801741183249(17) NGEXX133/(01)00801741183249(17) NGEY0842/(01)00801741183249(17) NGEZ1823/(01)00801741183249(17)

Source

Official record: FDA (Device enforcement) ↗

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

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