The Recall Desk
SevereFDA (Devices)·Z-2291-2017·Announced 2017-06-14

Arrow PICC Recall Initiated Due to Safety Cover Disengagement and Needlestick Injury

Arrow International is recalling Arrow PICC products with Chlorag+ard Technology 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 reported needlestick injuries, which constitute significant injury reports, meeting the criteria for a Severe (Score 4) classification under the rubric.

Plain-English summary

Arrow International has initiated a recall of Arrow PICC products with Chlorag+ard Technology. The recall is due to reports of safety cover disengagement and needlestick injuries associated with the BD Eclipse Needle, which is packaged with certain Arrow products.

The affected products are Arrow PICC devices, which permit venous access to the central circulation through a peripheral vein. The intended use of the associated VP'S Stylet and Console (VPS System) is to guide central catheters to the lower third of the superior vena cava or the cavo-atrial junction. The specific material number for the affected items is CDA-45063-HPK1A.

The firm reports that a total of 43,394 devices were distributed nationwide. Users of these products should stop using the affected PICC devices and contact Arrow International for further instructions or replacement.

The recalled product

Product
Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein. The intended use of the VP'S Stylet and Console (VPS System) is to quickly and accurately guide market available central catheters to the desired 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 CDA-45063-HPK1A

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 →