FDA Device recall Z-0486-2018
Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to oth…
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to oth… by Arrow International, citing needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0486-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-07-10 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International |
| Distribution | n/a |
Product
Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.
Reason
Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.
Identifiers
| code_info | Lot Numbers: 1) 23F16H0859 & 2) 23F16J0547 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0486-2018%22
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