Medical device recalls Moderate risk

Cather recalled over mold contamination

Recall date
February 17, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Arrow International Inc recalls Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central…
Recall number
Z-2772-2016
FDA classification
Class II
Brand / firm
Arrow International Inc
Sold / distributed
US Distribution to states of: NC, OH, FL, and MD.

Why it was recalled

Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

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

What was recalled

Cather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.

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