Regard CV PK, Item Numbers a) 880289014, b) 880289015 recallZ-0315-2024 · ROi CPS LLC · initiated Sep 21, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from ROi CPS LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Other
What the company is doing
ROi CPS, LLC issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its sole consignee on 09/29/2023 via email. The email attached the notice and the notice received from Getinge. The notice explained the issue, the potential risks, and requested the distributor notify their customer. End user was directed to post the Getinge notice in area where the affect kits were used. An updated notice was sent on 10/13/2023 via email with the corrected item numbers with the same instructions.
Recall details
- Recall number
- Z-0315-2024
- Status
- Open, Classified
- Initiated by the company
- Sep 21, 2023
- Posted by the FDA
- Nov 16, 2023
- Recalling firm
- ROi CPS LLC
- Quantity
- 134 units
- Product code
- OEZ
- Distribution
- MO
Product description
Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Code information (models, lots, serial numbers)
a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Regard™ CV00440NRoi Cps, LLC · Cardiovascular Procedure Kit1 recall0 reports
- Regard™ CV00440ORoi Cps, LLC · Cardiovascular Procedure Kit1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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