FDA Device recall Z-1960-2018
Spring Wire Guide Introducer Needle
- FDA Device
- Class II
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class II recall of Spring Wire Guide Introducer Needle 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-1960-2018 |
| 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
Spring Wire Guide Introducer Needle; Product Codes: AN-04320 and AN-04418
Reason
Product sterility may be compromised due to unsealed packaging.
Identifiers
| code_info | Lot Numbers: Product code AN-04320: 13F17A0131,13F17B0101,13F17B0320,13F17D0234, 13F17F0242,13F17H0488,13F17J0454,13…Lot Numbers: Product code AN-04320: 13F17A0131,13F17B0101,13F17B0320,13F17D0234, 13F17F0242,13F17H0488,13F17J0454,13F17M0003 Product code AN-04418: 13F17F0738 and 13F17J0445 |
|---|
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-1960-2018%22
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