[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
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Radial Artery Catheterization Kit; Model: AK-04220 |
|---|---|
| Brand / manufacturer | Arrow International Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1286-2018 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 26 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.