FDA Device recall Z-1969-2018
Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions
- FDA Device
- Class II
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class II recall of Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions by Arrow International, citing product sterility may be compromised due to unsealed packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1969-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-11 |
| Published | 2018-06-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International |
| Distribution | US |
Product
Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
Reason
Product sterility may be compromised due to unsealed packaging.
Identifiers
| code_info | Lot Numbers: 13F17E0562 13F17G0537 13F17K0188 13F17L0167 |
|---|
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-1969-2018%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.