FDA Device recall Z-1989-2018
ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit
- FDA Device
- Class II
- terminated
- Published 2018-06-06
On 2018-06-06 the FDA classified a Class II recall of ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit 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-1989-2018 |
| 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
ARROWg+ard Blue PLUS¿ Pressure Injectable Quad-Lumen CVC Kit; Product Codes: CDC-42854-P1A and CDC-45854-P1A
Reason
Product sterility may be compromised due to unsealed packaging.
Identifiers
| code_info | Lot numbers: Product code CDC-42854-P1A: 13F17C0137 13F17E0177 13F17E0598 13F17F0644 13F17G0287 13F17H0118 13F…Lot numbers: Product code CDC-42854-P1A: 13F17C0137 13F17E0177 13F17E0598 13F17F0644 13F17G0287 13F17H0118 13F17K0156 13F17L0017 13F17M0158 Product code CDC-45854-P1A: 13F17C0396 13F17C0439 13F17D0062 13F17D0284 13F17E0618 13F17F0126 13F17G0293 13F17H0263 13F17J0055 13F17K0168 13F17L0021 13F17L0353 13F17L0590 |
|---|
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-1989-2018%22
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