Medical device recalls Moderate risk

Arrow International Inc recalls Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Cathete…

Recall date
March 20, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2282-2017
FDA classification
Class II
Brand / firm
Arrow International Inc
Sold / distributed
Nationwide Distribution

Why it was recalled

Arrow International initiated the recall due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow 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

Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 5 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node

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