Radial Artery Catheterization Kit — Class II medical device recall Z-1286-2018
Terminated recall by Arrow International Inc, reported 2018-04-11, distributed nationwide. The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month s
| Recall number | Z-1286-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arrow International Inc, Reading, PA, United States |
| Recall initiated | 2017-10-26 |
| Classified | 2018-04-02 |
| Reported by FDA | 2018-04-11 |
| Terminated | 2019-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 6,358 |
| Reason classes | labeling |
| Lot numbers | 13F16H0429, 13F16M0214, 13F17F0281, 23F16H0161, 23F16J0018 |
| Model numbers | AK-04220 |
| Expiration dates | 2018-10-20 |
Product
Radial Artery Catheterization Kit; Model: AK-04220
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1286-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.