FDA Device recall Z-1994-2018
ARROWg+ard Blue PLUS¿ Pressure Injectable Multi-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 Multi-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-1994-2018 |
| 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 Multi-Lumen CVC Kit; Product Codes: CDC-45703-P1A; CDC-45703-PB1A; CDC-42703-P1A; and CDC-15703-P1A
Reason
Product sterility may be compromised due to unsealed packaging.
Identifiers
| code_info | Lot Numbers: Product Code CDC-45703-P1A: 13F17J0061 13F17J0084 13F17J0451 13F17K0249 13F17K0250 13F17K0383 13F…Lot Numbers: Product Code CDC-45703-P1A: 13F17J0061 13F17J0084 13F17J0451 13F17K0249 13F17K0250 13F17K0383 13F17K0575 13F17L0576 13F17M0154 Product code CDC-45703-PB1A: 13F17B0350 13F17E0048 13F17E0719 13F17H0308 13F17L0099 Product code CDC-42703-P1A: 13F16M0232 13F17J0065 13F17J0450 13F17K0069 13F17K0136 13F17K0288 13F17K0419 13F17K0567 13F17L0223 13F17L0573 Product code CDC-15703-P1A: 13F17A0025 13F17E0279 13F17E0457 13F17F0160 13F17F0769 13F17G0349 13F17J0133 13F17J0134 13F17L0103 13F17M0200 |
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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-1994-2018%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.