FDA Device recall Z-1957-2018
Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires
- FDA Device
- Class II
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class II recall of Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires 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-1957-2018 |
| 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
Catheter Hemostasis Valve For use with .038" (.096 cm) dia. and smaller guide wires; Product Code: AI-07000
Reason
Product sterility may be compromised due to unsealed packaging.
Identifiers
| code_info | Lot Numbers: 13F17C0232 13F17G0194 13F17H0047 13F17J0083 |
|---|
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-1957-2018%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.