Bard Peripheral Vascular Inc: BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature.

Is my product affected?

BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidewire during access into the vasculature.

• UPC 00801741067907

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

What happened

Bard Peripheral Vascular Inc. is recalling 130 units of the BARD PERIPHERAL VASCULAR SEEKER® Crossing Support Catheter (0.014", 150 cm, REF SK15014) distributed nationwide. The catheter is used to support a guidewire during vascular access. The recall was issued because the packaging hoop that holds the catheter during packaging may have detectable levels of bacterial endotoxin on it, which could potentially cause cross-contamination in a clinical setting. The catheter itself contains acceptable endotoxin levels.

The affected lot is VTBZ0193 (UDI: (01)00801741067907(17)191207(10)VTBZ0193, dated 191207). The source document does not specify what action 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: 130 units Lot/code info: UDI: (01)00801741067907(17)191207(10)VTBZ0193, Lot Number: VTBZ0193

Source

Official record: FDA (Device enforcement) ↗

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

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