Regard CV PK cardiovascular convenience kits with specific item numbers and lot numbers recalled due to insufficient setup instructions for chest drains, potentially causing injury.
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.
Take action
Contact the company
📍Recalling firmROi CPS LLC3000 E Sawyer Rd · Republic, MO 65738-2758
“Regard CV PK Cardiovascular Kit Recall: Inadequate Setup Instructions Risk Injury.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/57286-regard-cv-pk-cardiovascular-kit-recall-inadequate-setup-instructions-risk. Based on FDA recall #Z-0315-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0315-2024%22&limit=1).
ROi CPS LLC is voluntarily recalling Regard CV PK cardiovascular convenience kits due to insufficient setup instructions for catheter connections, the FDA said on Sept. 21, 2023. The recall covers 134 units distributed in Missouri.
How to tell if you have it
Brand: ROi CPS
Product: Regard CV PK
Item Number a) 880289014, Lot Numbers: 94114, 95436; UDI/DI 10194717111702
Item Number b) 880289015, Lot Numbers: 96442; UDI/DI 10194717117049
The hazard
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.
Context
GovInfoNow's records show ROi CPS LLC has 27 other recalls on record since Jan. 3, 2020. Other recent recalls include a Dec. 26, 2024 newborn kit recall for potential loss of positive pressure and a July 24, 2024 medical convenience kit recall involving Merit syringes. Similar recent recalls of similar products include an June 29, 2026 American Contract Systems Convenience Kit Recall regarding catheter performance standards and a May 4, 2026 Medline Medical Procedure Kits Recall for catheter issues.
How to tell if you have this one
Check for item numbers 880289014 or 880289015 on the Regard CV PK cardiovascular convenience kits. The kits were sold with specific lot numbers: 94114, 95436 for one model and 96442 for the other.
Brand
ROi CPS
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Details
Identify the item number and lot number on your Regard CV PK cardiovascular convenience kit to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed in Missouri.
Listed by the agency
Not listed
FDA distribution: “MO” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Missouri.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0315-2024 (September 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0315-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.