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Lower risk Medical device recall · FDA · Published November 10, 2020

Baxter MiniCap Extended Life PD Transfer Set Recall: Potential No-Flow Leaks

Baxter Healthcare recalls MiniCap Extended Life PD Transfer Sets with potential no-flow and leaks under twist clamp. Affected units have specific product codes and expiration dates. Contact Baxter for details.

🇺🇸 FDA recall #Z-0768-2021Medical deviceBaxter Healthcare ›
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Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625
✎ GovInfoNow plain-language explainer

What happened, in plain English

Baxter Healthcare is recalling MiniCap Extended Life PD Transfer Sets that may leak or stop flowing due to a twist clamp issue. This could cause problems during medical fluid transfers if not fixed. Read more at govinfonow.com/recall/63947-baxter-minicap-extended-life-pd-transfer-set-recall-potential-no.

Source Summary by GovInfoNow · govinfonow.com/recall/63947-baxter-minicap-extended-life-pd-transfer-set-recall-potential-no · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0768-2021

Cite this page

“Baxter MiniCap Extended Life PD Transfer Set Recall: Potential No-Flow Leaks.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63947-baxter-minicap-extended-life-pd-transfer-set-recall-potential-no. Based on FDA recall #Z-0768-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0768-2021%22&limit=1).

Why it’s dangerous

The twist clamp in these sets can become loose, causing no-flow or leaks. This may lead to improper fluid delivery during medical treatments, potentially causing complications.

Who’s affected

Patients using medical infusion systems with this specific product are most at risk. Healthcare facilities and individuals with medical devices may be affected.

How to tell if you have this one

Check for product codes: 5C4482, UDI: 00085412007731, and expiration dates listed in the recall notice. The sets were sold with specific lot numbers and dates between April and August 2025.

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

What to do — step by step

  1. Check Product Details

    Look for the product code 5C4482 and expiration dates listed in the recall notice to confirm if your set is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

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: “Worldwide and US (Nationwide), Canada, Brazil, Mexico, Bermuda, and Indonesia” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

1. Firm started the recall: Nov 10, 202012. FDA classified it Class II: Jan 4, 202123. Published in FDA’s Enforcement Report: Jan 13, 202134. FDA terminated the recall: Mar 24, 2023420202023
  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.

✎ GovInfoNow

Questions people ask

Is this product dangerous?

The recall indicates a potential for no-flow and leaks under the twist clamp, which could affect medical fluid delivery. However, the hazard is not described as causing serious injury in normal use.

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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-0768-2021 (November 10, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0768-2021 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