ROi CPS Recalls Regard Custom Procedure Kits with BD Luer Lok Devices
ROi CPS recalls Regard Custom Procedure Kits containing BD Luer Lok Access Devices due to packaging in convenience kits. Affected kits include specific item numbers and lots.
Recall notice
Recalled devices were packaged in convenience kits.
Contact the company
What happened, in plain English
ROi CPS is recalling Regard Custom Procedure Kits that contain BD Luer Lok Access Devices because they were packaged in convenience kits. This recall affects specific item numbers and lots of kits sold for IV start labor birth procedures. Read more at govinfonow.com/recall/61042-roi-cps-recalls-regard-custom-procedure-kits-with-bd-luer.
Source Summary by GovInfoNow · govinfonow.com/recall/61042-roi-cps-recalls-regard-custom-procedure-kits-with-bd-luer · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0837-2022
Cite this page
“ROi CPS Recalls Regard Custom Procedure Kits with BD Luer Lok Devices.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61042-roi-cps-recalls-regard-custom-procedure-kits-with-bd-luer. Based on FDA recall #Z-0837-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0837-2022%22&limit=1).
Why it’s dangerous
The recall states that the devices were packaged in convenience kits, but it does not explain why this packaging is dangerous or what specific hazard exists. Without clear hazard details, the risk level cannot be determined.
Who’s affected
Healthcare providers using Regard Custom Procedure Kits for IV start labor birth procedures are likely affected. Those with the specific item numbers and lots listed in the recall are at risk.
How to tell if you have this one
Check if your Regard Custom Procedure Kit contains BD Luer Lok Access Devices with item numbers 830110 (lots 89222, 87572) or 830110002 (lots 91226, 90641, 90446). These kits were sold for IV start labor birth procedures.
- Brand
ROi CPS- Category
Medical device
What to do — step by step
Check Kit Details
Identify if your kit has the specific item numbers and lots listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of Missouri.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0837-2022 (February 24, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0837-2022 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.