ROi CPS CV Minor Kit Sterile Recall: Nonsterile Component in Sterile Kit
ROi CPS recalls sterile CV Minor Kit (Item #800774001) due to nonsterile component packaging. Affected kits may pose infection risks if used without proper sterilization.
Lower-risk recall
A nonsterile component was packaged in a sterile convenience kit.
Contact the company
What happened, in plain English
ROi CPS is recalling sterile CV Minor Kits that contain a nonsterile component. Using these kits without proper sterilization could lead to infections. Read more at govinfonow.com/recall/60682-roi-cps-cv-minor-kit-sterile-recall-nonsterile-component-in.
Source Summary by GovInfoNow · govinfonow.com/recall/60682-roi-cps-cv-minor-kit-sterile-recall-nonsterile-component-in · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1295-2022
Cite this page
“ROi CPS CV Minor Kit Sterile Recall: Nonsterile Component in Sterile Kit.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/60682-roi-cps-cv-minor-kit-sterile-recall-nonsterile-component-in. Based on FDA recall #Z-1295-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1295-2022%22&limit=1).
Why it’s dangerous
The sterile kit contains a nonsterile component, which means it cannot be used for procedures requiring complete sterility. This could lead to infections if the kit is used without proper sterilization steps.
Who’s affected
Healthcare professionals using sterile surgical kits for procedures are most at risk. Patients using these kits without proper sterilization could face infection risks.
How to tell if you have this one
Check for the item number 800774001 and lot number 91423 with expiration date 02/08/2024 on the kit packaging.
- Brand
ROi CPS- Product
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile- Category
Medical device
What to do — step by step
Check Kit Packaging
Look for item number 800774001 and lot number 91423 with expiration date 02/08/2024.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of FL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-1295-2022 (May 20, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1295-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.