The Recall Desk
HighFDA (Devices)·Z-0468-2014·Announced 2013-12-18

Arrow Transradial Artery Access Products Recalled for Occluded Needles

Arrow International Inc is recalling Transradial Artery Access products because introducer needles may be occluded, posing a risk of delayed treatment or adverse events.

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 is classified as FDA Class II, and the source text identifies a risk of adverse events and delayed treatment without reporting specific injuries or fatalities, aligning with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Arrow International Inc is recalling Arrow Transradial Artery Access products. These products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes. The recall involves 294,430 units distributed nationwide in the United States and internationally to Australia, Brazil, Canada, China, Ireland, New Zealand, Singapore, and Thailand.

The recall is being conducted because there is a risk that the introducer needles packaged within the kits can be partially or fully occluded. This defect can cause delayed treatment or an adverse event when the products are used on a patient.

Healthcare providers and facilities should check their inventory for the affected catalog numbers, lot numbers, and expiration dates listed in the official recall notice. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations.

The recalled product

Product
Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
Manufacturer
Arrow International Inc
Category
Medical Device — Vascular Access
Hazard
Affected units
294,430

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 (20)

  • Multiple: Expressed as Catalog # (AA#) lot number (RF#)
  • AA-15611-S RF1070730 2016-07
  • AA-15611-S RF0022652 2015-03
  • AA-15511-S RF1070880 2016-07
  • AA-15511-S RF0033719 2015-03
  • AA-15611-S RF1071062 2016-07
  • AA-15511-S RF0046459 2015-04
  • AA-15611-S RF1071206 2016-08
  • AA-15611-S RF0046461 2015-04
  • AA-15511-S RF1071354 2016-07
  • AA-15611-S RF0048269 2015-05
  • AA-15611-S RF1071757 2016-08
  • AA-15511-S RF0059652 2015-06
  • AA-15511-S RF1071798 2016-08
  • AA-15511-S RF0062416 2015-06
  • AA-15611-S RF1082042 2016-08
  • AA-15611-S RF0062419 2015-06
  • AA-15611-S RF1082374 2016-08
  • AA-15611-S RF0087575 2015-08
  • AA-15611-S RF1082709 2016-08

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Arrow International Inc

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Same hazard · device occlusion

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