Z-0315-2024Class II

Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit

Name: Z-0315-2024 Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Creator: ROi CPS LLC
Published: 2023-09-21
License: https://open.fda.gov/license/

ROi CPS LLC / initiated 2023-09-21 / Open, Classified / root cause: labeling and UDI

FDA source

ROi CPS LLC began a recall of Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit on 2023-09-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0315-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-21
Posted: 2023-11-16
Recalling firm: ROi CPS LLC
Product: Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit
Product code: OEZ Cardiovascular Procedure Kit
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: 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.
Quantity in commerce: 134 units
Distribution: MO
Product codes and lots: a) UDI/DI 10194717111702, Lot Numbers: 94114, 95436; b) UDI/DI 10194717117049, Lot Numbers: 96442

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0315-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0315-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-22	2023-11-16

Product code OEZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)