The Recall Desk
SevereFDA (Devices)·Z-2286-2017·Announced 2017-06-14

Arrow PICC Recall Due to Safety Cover Disengagement and Needlestick Risk

Arrow International is recalling Arrow PICC devices with Chlorag+ard Technology because the packaged BD Eclipse Needle safety cover may disengage, posing a needlestick injury risk.

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 risk under the severity rubric.

Plain-English summary

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

The affected devices are indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and central venous pressure monitoring. The recall covers devices with material number CDA-44041-HPK1A. The firm reports that a total of 43,394 devices were distributed nationwide.

Healthcare facilities and consumers should stop using the affected devices and contact Arrow International for further instructions on how to return or replace the products.

The recalled product

Product
Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infu
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-44041-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 →