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.
Other recalls by Roi Cps
- regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator
FDA Device · Class I · 2025-02-12 · Roi Cps - regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
FDA Device · Class II · 2024-09-25 · Roi Cps - Regard Kit containing the Microtek decanter
FDA Device · Class II · 2024-08-28 · Roi Cps - regard Operative LAP, Item Number 800943001
FDA Device · Class I · 2024-01-24 · Roi Cps - Regard Dressing change kit, Item Number 800026006
FDA Device · Class I · 2024-01-10 · Roi Cps
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0315-2024%22
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