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Lower risk Medical device recall · FDA · Published December 27, 2019

Cook Dawson-Mueller Drainage Catheter Recall: Leakage Risk

Cook recalls specific lots of Dawson-Mueller Drainage Catheter due to potential leakage from Mac-Loc hub assembly. Affected units may cause fluid buildup; contact for return or replacement.

🇺🇸 FDA recall #Z-0815-2020Medical deviceCook ›
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Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
✎ GovInfoNow plain-language explainer

What happened, in plain English

Cook is recalling specific lots of Dawson-Mueller Drainage Catheter because some units may leak from the Mac-Loc hub assembly. This could lead to fluid buildup around the insertion site, increasing infection risk. Affected customers should stop using the device and contact Cook for a replacement. Read more at govinfonow.com/recall/66198-cook-dawson-mueller-drainage-catheter-recall-leakage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/66198-cook-dawson-mueller-drainage-catheter-recall-leakage-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0815-2020

Cite this page

“Cook Dawson-Mueller Drainage Catheter Recall: Leakage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66198-cook-dawson-mueller-drainage-catheter-recall-leakage-risk. Based on FDA recall #Z-0815-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0815-2020%22&limit=1).

Why it’s dangerous

The Mac-Loc hub assembly in certain lots may leak, causing fluid buildup around the insertion site. This could increase the risk of infection or discomfort for patients using the catheter.

Who’s affected

Patients using the Dawson-Mueller Drainage Catheter for medical drainage are most at risk. The recall affects specific model numbers sold between 2019 and 2023.

How to tell if you have this one

Check the product's model number on the packaging or label. Affected units include specific serial numbers listed in the recall notice, such as 9799196, 9909433, and others.

  • Brand
    Cook
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using the Device

    Immediately stop using the Dawson-Mueller Drainage Catheter if it has the affected model numbers listed in the recall.

  2. Contact Cook for Replacement

    Reach out to Cook Inc. to arrange a replacement or refund for the affected units.

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: “Nationwide domestic distribution. Foreign distribution to Australia, Belgium, Canada, China, Colombia, Denmark, France, Germany, Italy, Korea, Netherlands, New Zealand, Peru, Russia, Spain, Sweden, and United Kingdom.” 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 11 months after the firm started it.

1. Firm started the recall: Dec 27, 201912. FDA classified it Class II: Jan 16, 202023. Published in FDA’s Enforcement Report: Jan 22, 202034. FDA terminated the recall: Nov 23, 2020420192020
  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-0815-2020 (December 27, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0815-2020 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