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Use caution Medical device recall · FDA · Published January 3, 2020

ROi CPS Custom Procedure Packs Recall: Risk of Incorrect Use During Surgery

ROi CPS LLC recalls custom procedure packs with Clearlink Continu-Flo devices due to potential incorrect use during surgical procedures. Affected items include specific model numbers and lot numbers.

🇺🇸 FDA recall #Z-0918-2020Medical deviceROi CPS ›
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Contact the company

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

ROi CPS LLC recalled custom procedure packs containing Clearlink Continu-Flo devices because they were manufactured with devices that could be used incorrectly during surgery. This recall affects specific model numbers and lot numbers listed in the product description. Read more at govinfonow.com/recall/66166-roi-cps-custom-procedure-packs-recall-risk-of-incorrect-use.

Source Summary by GovInfoNow · govinfonow.com/recall/66166-roi-cps-custom-procedure-packs-recall-risk-of-incorrect-use · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0918-2020

Cite this page

“ROi CPS Custom Procedure Packs Recall: Risk of Incorrect Use During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66166-roi-cps-custom-procedure-packs-recall-risk-of-incorrect-use. Based on FDA recall #Z-0918-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0918-2020%22&limit=1).

The FDA announced on Jan. 3, 2020, that ROi CPS LLC is recalling custom procedure packs containing Clearlink Continu-Flo devices. The hazard stems from the inclusion of devices previously recalled by Baxter Healthcare Corporation.

How to tell if you have it

  • Brand: ROi CPS
  • Product: Custom procedure packs containing Clearlink Continu-Flo
  • Item Number 830015012, Lot Numbers 72700L, 74508L
  • Item Number 830027, Lot Numbers 72702C, 74406C
  • Item Number 830026, Lot Number 72897B
  • Item Number 830024, Lot Numbers 73325B, 74403B
  • Item Number 880189011, Lot Numbers 73173K, 74855K
  • Item Number 830028, Lot Number 73666B
  • Item Number 830084, Lot Number 74354B
  • Item Number 830014, Lot Number 74373N
  • Item Number 830034, Lot Number 68336D
  • Distribution: AR, OK, MO, KS

The hazard

ROi CPS LLC manufactured custom procedure packs using Clearlink Continu-Flo devices which were subsequently recalled by Baxter Healthcare Corporation.

Context

GovInfoNow's records show ROi CPS LLC has 27 other recalls on record since April 20, 2020. Other recent recalls of similar products include Medline ARTHROSCOPY PACK Recall (Feb. 25, 2026), Windstone Custom Convenience Kits Pre Op Kit Recall (March 11, 2026), and Bard PowerPICC Provena Catheters Recall (May 21, 2026).

How to tell if you have this one

Check for product labels with model numbers like LD00200L-VAG DELIVERY MOTHER or GS00310C, and lot numbers such as 72700L or 74508L. These packs were sold in specific locations including Joplin and Lebanon.

  • Brand
    ROi CPS
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Labels

    Look for model numbers and lot numbers on the product labels to confirm if your item is affected.

Where it went and when

Where it was distributed

Distributed in 4 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: yesMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: yesKSArkansas: yesARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

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

States: Arkansas, Kansas, Missouri, Oklahoma.

Recall timeline

FDA terminated this recall 11 months after the firm started it.

1. Firm started the recall: Jan 3, 202012. FDA classified it Class II: Jan 30, 202023. Published in FDA’s Enforcement Report: Feb 5, 202034. FDA terminated the recall: Nov 20, 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-0918-2020 (January 3, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0918-2020 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