Bard Peripheral Vascular Inc: BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature.

Is my product affected?

BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm, REF SK15035M. Intended to support a guidewire during access into the vasculature.

• UPC 00801741067921

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

What happened

Bard Peripheral Vascular Inc. is recalling 140 units of the BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.035", 150 cm (REF SK15035M) distributed nationwide. The catheter is designed to support a guidewire during access into the vasculature. The devices are at risk of having detectable levels of bacterial endotoxin present on the packaging hoop, which could potentially cause cross-contamination in a clinical setting, though the bacterial endotoxin levels on the catheters themselves are within acceptable levels.

The affected lot number is VTBY0563, with a UDI of (01)00801741067921(17)191115(10)VTBY0563. The source document does not specify what actions affected consumers should take in response to this recall.

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

Hazard

Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting.

Details from the source

Reason for recall: Device is at risk of having detectable levels of bacterial endotoxin present on the packaging hoop that the catheter is packaged in. The bacterial endotoxin levels for the catheters are within acceptable levels; however, if bacterial endotoxins are present on the packaging hoops it may have the potential for cross-contamination in a clinical setting. Distribution: Nationwide Distribution Quantity: 140 units Lot/code info: UDI: (01)00801741067921(17)191115(10)VTBY0563, Lot Number: VTBY0563

Source

Official record: FDA (Device enforcement) ↗

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

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