ROi CPS Nonsterile Kits Recall: Sterile Components in Nonsterile Packaging
ROi CPS recalls two nonsterile convenience kits with sterile components mistakenly packaged in nonsterile kits. This could lead to infection risks during medical procedures.
Lower-risk recall
Some nonsterile components that were supposed to be sterile were packaged in nonsterile kits.
Contact the company
What happened, in plain English
ROi CPS is recalling two specific nonsterile convenience kits because they accidentally included sterile components in nonsterile packaging. This poses a risk of infection if used for medical procedures. Read more at govinfonow.com/recall/60552-roi-cps-nonsterile-kits-recall-sterile-components-in-nonsterile-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/60552-roi-cps-nonsterile-kits-recall-sterile-components-in-nonsterile-packaging · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1407-2022
Cite this page
“ROi CPS Nonsterile Kits Recall: Sterile Components in Nonsterile Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60552-roi-cps-nonsterile-kits-recall-sterile-components-in-nonsterile-packaging. Based on FDA recall #Z-1407-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1407-2022%22&limit=1).
Why it’s dangerous
The kits were supposed to be nonsterile but contained sterile components that could lead to infections if used improperly. This happens because the sterile parts were mistakenly packaged in nonsterile kits.
Who’s affected
Healthcare professionals and medical facilities that use these kits for procedures. Those handling sterile components without proper checks are at higher risk.
How to tell if you have this one
Check for item numbers: 830099008 (CV01005H - CV Part 1 Bundle) or 830019017 (CV00214Q - CV). The kits have specific expiration dates and unique identifiers.
- Brand
ROi CPS- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Distribution was made to MO. There was no foreign/military/government distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1407-2022 | Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.; (1) Item #830099008 - Lot #92534, exp. 11/13/2022, UDI #10194717114895; (2) Item #830019017 - Lot #92612, exp. 8/31/2023, UDI #10194717113249. | 86 kits |
| Z-1408-2022 | Nonsterile convenience kit: regard Item #830014016, LD00199P - C Section Mother.; Lot #92605, exp. 8/31/2023, Item #830014016, UDI #10194717110156. | 40 kits |
What to do — step by step
Check Kit Details
Look for item numbers 830099008 or 830019017 on the kit packaging.
Where it went and when
Where it was distributed
Distributed in Missouri.
FDA distribution: “Distribution was made to MO. There was no foreign/military/government distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Missouri.
Recall timeline
FDA terminated this recall 10 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.
Questions people ask
Do I need to stop using these kits?
The recall does not require immediate stop use; check the item numbers to confirm if you have the recalled kits.
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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-1407-2022 (June 3, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1407-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.