Bard Peripheral Vascular Inc recalls BARD PERIPHERAL VASCULAR SEEKER(R) Crossing Support Catheter, 0.014", 150 cm, REF SK15014. Intended to support a guidew…

Recall date

April 16, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1803-2018

FDA classification

Class II

Brand / firm

Bard Peripheral Vascular Inc

Sold / distributed

Nationwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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