C.R. Bard Inc: BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C

Is my product affected?

BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C

• UPC 00801741183232

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

What happened

C.R. Bard Inc. has recalled 2,120 units of BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr (Reference INTS14C) due to a potential leak at the connection point between the catheter and drain bag. The affected product was distributed nationwide across Georgia, Maine, New Jersey, Wisconsin, Minnesota, South Dakota, Colorado, North Dakota, Idaho, Illinois, Florida, Louisiana, Maryland, Pennsylvania, Ohio, and Nebraska. The recalled units are identified by the serial numbers/UDIs: NGEWX106, NGEWX143, NGFQ0368, and NGEW9106, all with UDI (01)00801741183232(17).

The source document does not specify a remedy or recommended action for consumers who may have received 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: 2120 units Lot/code info: Serial Number/UDI NGEWX106/(01)00801741183232(17) NGEWX143/(01)00801741183232(17) NGFQ0368/(01)00801741183232(17) NGEW9106/(01)00801741183232(17)

Source

Official record: FDA (Device enforcement) ↗

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

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