The Recall Desk
SevereFDA (Devices)·Z-2284-2017·Announced 2017-06-14

Arrow VPS Access Kit Recalled for Needlestick Injury Risk

Arrow International is recalling VPS Access Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device with reported needlestick injuries, which constitutes a significant injury report under the severity rubric.

Plain-English summary

Arrow International Inc. has initiated a recall of the Arrow(R) VPS(R) Access Kit for use with 5 Fr. Peripherally Inserted Central Venous Catheter. The recall is due to reports of safety cover disengagement and needlestick injury for the BD Eclipse Needle that are packaged with certain Arrow products.

The VPS System is intended to quickly and accurately guide peripherally inserted central catheters (PICCs) to the goal location near the sino-atrial node. The recall involves material number ASK-04001-DU9. The firm reports that a total of 43,394 devices were distributed nationwide.

Healthcare facilities and consumers should stop using the affected Arrow VPS Access Kits and contact Arrow International for further instructions or a replacement. Users should be aware of the potential for needlestick injuries if the safety cover of the packaged BD Eclipse Needle disengages.

The recalled product

Product
Arrow(R) VPS(R) Access Kit 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 wh
Affected units
43,394

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Material number ASK-04001-DU9

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 56 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 56 products in this recall →