The Recall Desk
SevereFDA (Devices)·Z-2299-2017·Announced 2017-06-14

Arrow Arterial Catheterization Kits Recalled for Needlestick Injury Risk

Arrow International is recalling Arterial Catheterization 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 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 Inc. has initiated a recall of Arterial Catheterization Kits with Maximal Barrier Precautions. The recall is driven by reports of safety cover disengagement and needlestick injuries involving the BD Eclipse Needle, which is packaged with certain Arrow products.

The affected devices are identified by material number ASK-04500-BGH. The firm reports that a total of 43,394 devices were distributed nationwide. The Arrow Arterial Catheterization device is designed to permit access to the peripheral arterial circulation or other small vessels.

Healthcare facilities and users should stop using the affected kits and contact Arrow International for further instructions regarding the recall and potential replacement or refund.

The recalled product

Product
Arterial Catheterization Kit with Maximal Barrier Precautions The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels
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-04500-BGH

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 →