FDA Device recall Z-0658-2018
ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions
- FDA Device
- Class II
- terminated
- Published 2018-02-28
On 2018-02-28 the FDA classified a Class II recall of ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions by Arrow International, citing these finished good kits may contain the incorrect Springwire Guide (SWG).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0658-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-17 |
| Published | 2018-02-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Arrow International |
| Distribution | US |
Product
ARROWg+ard Blue Two Lumen Hemodialysis Catheterization Kit for High Volume Infusions; Product Codes: AK-22142-CDC, AK-22142-F, AK-25142-CDC, AK-25142-F; Exp. Dates Feb 2018 - Nov 2018
Reason
These finished good kits may contain the incorrect Springwire Guide (SWG).
Identifiers
| code_info | Lot numbers: Product Code AK-22142-CDC: 13F17A0021 13F17A0315 Product Code AK-22142-F: 13F17B0338 13F17E0067…Lot numbers: Product Code AK-22142-CDC: 13F17A0021 13F17A0315 Product Code AK-22142-F: 13F17B0338 13F17E0067 Product Code AK-25142-CDC: 13F17E0340 Product Code AK-25142-F: 13F17A0207 |
|---|
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-0658-2018%22
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