FDA Device recall Z-1959-2018
Echogenic Introducer Needle
- FDA Device
- Class II
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class II recall of Echogenic 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-1959-2018 |
| 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
Echogenic Introducer Needle; Product Code: AN-04318
Reason
Product sterility may be compromised due to unsealed packaging.
Identifiers
| code_info | Lot Numbers: 13F17A0231 13F17B0321 13F17C0241 13F17D0233 13F17E0301 13F17E0725 13F17F0603 13F17G0193 13F17J00…Lot Numbers: 13F17A0231 13F17B0321 13F17C0241 13F17D0233 13F17E0301 13F17E0725 13F17F0603 13F17G0193 13F17J0089 13F17K0232 13F17L0230 13F17L0231 13F17L0232 13F17L0233 |
|---|
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-1959-2018%22
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