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Stop using now Medical device recall · FDA · Published August 8, 2025

Baxter Continu-Flo Solution Set Recall: Tubing Separation Risk

Baxter Healthcare recalls Continu-Flo solution sets with tubing separation risk. Affected units have specific lot numbers and expiration dates. Stop using immediately to prevent medical complications.

🇺🇸 FDA recall #Z-2594-2025Medical deviceBaxter Healthcare ›
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Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
✎ GovInfoNow plain-language explainer

Baxter Healthcare is recalling a specific type of IV tubing due to reports of tubing separation. This could lead to medical complications if the tubing separates during use. Read more at govinfonow.com/recall/51648-baxter-continu-flo-solution-set-recall-tubing-separation-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/51648-baxter-continu-flo-solution-set-recall-tubing-separation-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2594-2025

Cite this page

“Baxter Continu-Flo Solution Set Recall: Tubing Separation Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51648-baxter-continu-flo-solution-set-recall-tubing-separation-risk. Based on FDA recall #Z-2594-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2594-2025%22&limit=1).

The FDA announced on August 8, 2025, that Baxter Healthcare Corporation is recalling one lot of Continu-Flo solution sets due to tubing separation. This voluntary Class II recall affects 14,400 units distributed nationwide.

How to tell if you have it

  • Brand: Baxter Healthcare
  • Product: Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m)
  • Product Code REF 2C8519
  • UDI/DI 00085412048994
  • Lot Number R24I20079
  • Expiration Date: 9/21/2026

The hazard

The recall is due to customer reports of tubing separation. The FDA classified this as an Urgent Medical Device Recall.

Context

GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since September 2, 2015. Recent recalls include the August 18, 2026 PRO+ 40" MRS SURFACE Mattress Recall for incorrect labeling risk and the August 17, 2026 recalls of 0.9% Sodium Chloride Injection and Dextrose 2000mL Bags for particulate matter risks. Other recent recalls of similar products include the October 29, 2025 B Braun Anesthesia IV Set Recall for backflow risk and the October 29, 2025 B Braun IV Sets and Medical IV Extension Set Recalls for medication backflow risk.

How to tell if you have this one

Check for the product code REF 2C8519 and lot number R24I20079 on the tubing. The product expires September 21, 2026, and is used for intravenous administration.

  • Brand
    Baxter Healthcare
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    Discontinue use of the Continu-Flo solution set with lot number R24I20079 to prevent tubing separation risks.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 54 days after the firm started it.

1. Firm started the recall: Aug 8, 202512. FDA classified it Class II: Sep 19, 202523. Published in FDA’s Enforcement Report: Oct 1, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-2594-2025 (August 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2594-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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