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Lower risk Medical device recall · FDA · Published March 28, 2018

Medi-Vac Flex Advantage Suction Canister Liner Recall: Missing One-Way Valve Hazard

Cardinal Health recalls Medi-Vac Flex Advantage Suction Canister Liners with missing one-way valves that could cause fluid leaks during medical procedures. Affected models include REF 6561-910C and REF 6561-916K.

🇺🇸 FDA recall #Z-1546-2018Medical deviceCardinal Health ›
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Contact the company

Recalling firmCardinal Health 200, LLC3651 Birchwood Dr · Waukegan, IL 60085-8337
✎ GovInfoNow plain-language explainer

What happened, in plain English

Cardinal Health is recalling Medi-Vac Flex Advantage Suction Canister Liners that may be missing a one-way valve on the fluid patient port. This could lead to improper fluid drainage during medical procedures, potentially causing contamination or infection risks. Affected units have specific material and lot numbers listed in the recall notice. Read more at govinfonow.com/recall/71590-medi-vac-flex-advantage-suction-canister-liner-recall-missing-one.

Source Summary by GovInfoNow · govinfonow.com/recall/71590-medi-vac-flex-advantage-suction-canister-liner-recall-missing-one · Updated August 21, 2026 · FDA enforcement record: FDA #Z-1546-2018

Cite this page

“Medi-Vac Flex Advantage Suction Canister Liner Recall: Missing One-Way Valve Hazard.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/71590-medi-vac-flex-advantage-suction-canister-liner-recall-missing-one. Based on FDA recall #Z-1546-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1546-2018%22&limit=1).

Why it’s dangerous

The suction canister liners may be missing a one-way valve that prevents backflow of fluids. Without this valve, fluids could leak into the patient's system during medical procedures, increasing the risk of contamination or infection.

Who’s affected

Healthcare professionals and patients using Medi-Vac Flex Advantage Suction Canister Liners for medical procedures are most at risk if the one-way valve is missing.

How to tell if you have this one

Check the material number on the product: REF 6561-910C, REF 6561-916K, or REF 6561-920C. Also look for the lot numbers: J802-384, J802-391 for REF 6561-910C; J802-386 for REF 6561-916K; J802-396 for REF 6561-920C.

  • Brand
    Cardinal Health
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the material number and lot number on the product to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed in Massachusetts.

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: yesMAOregon: 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: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFL

FDA distribution: “US Distribution to the state of MA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Massachusetts.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

1. Firm started the recall: Mar 28, 201812. FDA classified it Class II: Apr 30, 201823. Published in FDA’s Enforcement Report: May 9, 201834. FDA terminated the recall: Nov 29, 201842018
  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-1546-2018 (March 28, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1546-2018 to see it in context.
  • Plain-language summary written by qwen3:4b on August 21, 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