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Unrated Medical device recall · FDA · Published April 20, 2020

Regard CVC Triple Lumen 20CM Non-Sulfa-Mercy Recall: Custom Kits Contain Affected Syringes

ROi CPS recalls Regard CVC Triple Lumen 20CM non Sulfa-Mercy items with lot numbers 68336DRW. These items contain PosiFlush syringes from a previous BD recall. Consumers should check their lot numbers and contact ROi CPS for details.

🇺🇸 FDA recall #Z-2265-2020Medical deviceROi CPS ›
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Contact the company

Recalling firmROi CPS LLC3000 E Sawyer Rd · Republic, MO 65738-2758
✎ GovInfoNow plain-language explainer

What happened, in plain English

ROi CPS is recalling Regard CVC Triple Lumen 20CM non Sulfa-Mercy items with lot number 68336DRW because they contain PosiFlush syringes that were previously recalled by BD. This could pose a risk if the syringes are used improperly. Read more at govinfonow.com/recall/65356-regard-cvc-triple-lumen-20cm-non-sulfa-mercy-recall-custom.

Source Summary by GovInfoNow · govinfonow.com/recall/65356-regard-cvc-triple-lumen-20cm-non-sulfa-mercy-recall-custom · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2265-2020

Cite this page

“Regard CVC Triple Lumen 20CM Non-Sulfa-Mercy Recall: Custom Kits Contain Affected Syringes.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65356-regard-cvc-triple-lumen-20cm-non-sulfa-mercy-recall-custom. Based on FDA recall #Z-2265-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2265-2020%22&limit=1).

Why it’s dangerous

The recall involves custom procedure kits containing PosiFlush syringes that were previously recalled by BD. If these syringes are used incorrectly, they could lead to potential safety issues.

Who’s affected

Healthcare professionals who use these CVC lines may be affected. Those using the recalled items with lot number 68336DRW are most at risk.

How to tell if you have this one

Check for lot number 68336DRW on the item. The product is labeled as Regard CVC Triple Lumen 20CM non Sulfa-Mercy with item number 830034.

  • Brand
    ROi CPS
  • Product
    Regard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Lot Number

    Look for lot number 68336DRW on the item label.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 3 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: named in the noticeARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US nationwide distribution in the states of MO, AR and OK.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arkansas, Missouri, Oklahoma.

Recall timeline

FDA terminated this recall 4 months after the firm started it.

1. Firm started the recall: Apr 20, 202012. FDA classified it Class II: Jun 5, 202023. Published in FDA’s Enforcement Report: Jun 17, 202034. FDA terminated the recall: Aug 21, 202042020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. 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-2265-2020 (April 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2265-2020 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA