The Recall Desk
SevereFDA (Devices)·Z-2285-2017·Announced 2017-06-14

Arrow PICC Kit Recalled Due to BD Eclipse Needle Safety Cover Issues

Arrow International is recalling certain PICC kits because the packaged BD Eclipse Needle has a safety cover that 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 report under the severity rubric.

Plain-English summary

Arrow International Inc. has initiated a recall of the Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology. The recall is driven by reports of safety cover disengagement and needlestick injury associated with the BD Eclipse Needle, which is packaged with certain Arrow products.

The affected product is 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 is limited to units containing the specific BD Eclipse Needle with the reported safety cover defect.

Healthcare facilities and distributors should check their inventory for the affected material number ASK-45552-SPH. Users should stop using the affected kits and contact Arrow International for instructions on return or replacement. The total number of devices distributed is reported as 43,394.

The recalled product

Product
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure Injectable P1CC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intrave
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-45552-SPH

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 →