The Recall Desk
HighFDA (Devices)·Z-2298-2017·Announced 2017-06-14

Arrow QuickFlash Radial Artery Catheterization Kit Recalled for Needlestick Risk

Arrow International is recalling QuickFlash Radial Artery Catheterization Kits due to reports of safety cover disengagement and needlestick injuries associated with packaged BD Eclipse Needles.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (needlestick injury) where injury has been reported, but the source does not specify FDA Class I or fatalities, fitting the High severity criteria for risk-of-harm products.

Plain-English summary

Arrow International Inc. has initiated a recall of the QuickFlash Radial Artery/Arterial Line Catheterization Kit. The device is designed to permit access to the peripheral arterial circulation or other small vessels. 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 recall affects the QuickFlash Radial Artery/Arterial Line Catheterization Kit with material number ASK-04500-AH. The firm reports that a total of 43,394 devices were distributed nationwide. The agency has classified this recall as Class II.

Healthcare facilities and users should stop using the affected kits and contact Arrow International Inc. for further instructions on the recall process.

The recalled product

Product
QuickFlash Radial Artery/Arterial Line Catheterization Kit 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-AH

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 →