FDA Device recall Z-0315-2024
Regard CV PK, Item Numbers a) 880289014, b) 880289015
- FDA Device
- Class II
- ongoing
- Published 2023-11-22
On 2023-11-22 the FDA classified a Class II recall of Regard CV PK, Item Numbers a) 880289014, b) 880289015 by Roi Cps, citing specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0315-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-21 |
| Published | 2023-11-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roi Cps |
| Distribution | MO |
Product
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Reason
Specific Regard kits contain the Gentige Chest Drain Products being recalled by Gentige. The Instructions for Use (IFU) for the chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains.
Identifiers
| code_info | a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0315-2024%22
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