PlainRecalls
FDA Devices Moderate Class II Terminated

Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 4 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

Reported: June 14, 2017 Initiated: March 20, 2017 #Z-2283-2017

Product Description

Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 4 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

Reason for Recall

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.

Details

Recalling Firm
Arrow International Inc
Units Affected
unknown-firm reports total devices distributed 43,394
Distribution
Nationwide Distribution
Location
Reading, PA

Frequently Asked Questions

What product was recalled? ▼
Arrow¿ VPS¿ Access Kit with Maximal Barrier Precautions for use with 4 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. Recalled by Arrow International Inc. Units affected: unknown-firm reports total devices distributed 43,394.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 14, 2017. Severity: Moderate. Recall number: Z-2283-2017.

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