FDA Device recall Z-0468-2014

Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into th…

• FDA Device
• Class II
• terminated
• Published 2013-12-18

On 2013-12-18 the FDA classified a Class II recall of Arrow Transradial Artery Access products Arrow Transradial Artery Access products are used for percutaneous introduction of devices into th… by Arrow International, citing there is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patie….

Read the official FDA Device notice

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.

Reason

There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.

Identifiers

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0468-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.