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[Recalled] Radial Artery Catheterization Kit; Model: AK-04220 — The povidone iodine prep pads included in certain kits and trays do not meet th… | FDA 2017-10-26

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductRadial Artery Catheterization Kit; Model: AK-04220
Brand / manufacturerArrow International Inc
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-1286-2018
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date26 October 2017

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Arrow International Inc

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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