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Lower risk Medical device recall · FDA · Published August 1, 2022

BD MaxGuard Drop Administration Set: Expiration Label Error Risks Infection

CAREFUSION recalls BD MaxGuard Drop Administration sets with incorrect 2027 expiration labels (should be 2025). Using expired sets may cause leaks and infection risks. Affected units have specific lot numbers.

🇺🇸 FDA recall #Z-1756-2022Medical deviceCAREFUSION ›
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Recalling firmCAREFUSION10020 Pacific Mesa Blvd · San Diego, CA 92121-4386
✎ GovInfoNow plain-language explainer

CAREFUSION is recalling BD MaxGuard Drop Administration sets that have expiration labels showing 2027 instead of the correct 2025. Using these expired sets could lead to leaks and infection risks for patients and healthcare workers. Read more at govinfonow.com/recall/60224-bd-maxguard-drop-administration-set-expiration-label-error-risks-infection.

Source Summary by GovInfoNow · govinfonow.com/recall/60224-bd-maxguard-drop-administration-set-expiration-label-error-risks-infection · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1756-2022

Cite this page

“BD MaxGuard Drop Administration Set: Expiration Label Error Risks Infection.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60224-bd-maxguard-drop-administration-set-expiration-label-error-risks-infection. Based on FDA recall #Z-1756-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1756-2022%22&limit=1).

The FDA announced on Aug. 1, 2022, that CAREFUSION is recalling BD MaxGuard Drop Administration sets due to incorrect expiration date labeling. The agency said the error could compromise product integrity and pose a risk of infection.

How to tell if you have it

  • Brand: CAREFUSION
  • Product: BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock
  • REF: MX4436
  • UDI-DI: 10885403237478
  • Lots: 22019074, 22019431, 22019075, 22019076
  • Quantity: 19,925 units

The hazard

The FDA said the product labels list an expiration year of 2027 instead of the correct 2025. If expired product is used, the integrity of the product may be compromised and may result in potential leaks and risk of infection to the patient and healthcare worker.

Context

GovInfoNow's records show CAREFUSION has two other recalls on record since June 9, 2021. On Aug. 2, 2021, CAREFUSION recalled SmartSite Products that may cause flow issues due to needle-free connector valve problems. On June 9, 2021, CAREFUSION recalled MaxPlus bi fuse extension sets because a validation lot failed leakage testing criteria. Other recent recalls of similar products include BD Ready-to-Use Hydrophilic Catheter 14 Fr (Nov. 29, 2025) and Cook Staged Extubation Set (March 5, 2026).

How to tell if you have this one

Check for BD MaxGuard Drop Administration sets with expiration labels showing 2027 (should be 2025). Affected units have lot numbers 22019074, 22019431, 22019075, or 22019076.

  • Brand
    CAREFUSION
  • Category
    Medical device
FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US: TN, FL, LA, VA, MI, OH, NC, WA, UT, TX, NV, AL, AR, IA, MA, CO, NY, SC, IN, KY, MO, MD, PA, CA, IL, SD, GA, MS, AZ, WV, ID, WY, VT, NM, OR, NJ, OK, KS, MN
Recall numberProduct, codes & lotsQuantity
Z-1752-2022BD MaxGuard Extension Set with 4-way stopcock, REF: M4058; UDI-DI: 10885403235788, Lots: 22019324, 22019323, 2201932246,900
Z-1753-2022BD MaxGuard Extension Set, REF: ME1069; UDI-DI: 10885403236037, Lots: 220190623,500
Z-1754-2022BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106; UDI-DI: 10885403236358, Lots: 22019311, 22019312, 22019313, 2201931454,050
Z-1755-2022BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141; UDI-DI: 10885403236471, Lots: 22029167, 22029168, 2202916937,550
Z-1756-2022BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436; UDI-DI: 10885403237478, Lots: 22019074, 22019431, 22019075, 2201907619,925
Z-1757-2022BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059; UDI-DI: 10885403237584, Lots: 22029431, 2202943217,250
Z-1758-2022BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166; UDI-DI: 10885403237652, Lots: 22029648600
Z-1759-2022BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171; UDI-DI: 10885403237669, Lots: 22029674100
Z-1760-2022BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433; UDI-DI: 10885403237782, Lots: 220190859,900
Based on the official FDA remedy

What to do — step by step

  1. Check Expiration Label

    Look for expiration labels showing 2027 instead of 2025 on the BD MaxGuard Drop Administration set.

Where it went and when

Where it was distributed

Distributed in 39 states.

Alaska: not listedAKMaine: not listedMEVermont: yesVTNew Hampshire: not listedNHWashington: yesWAIdaho: yesIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: not listedWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: not listedCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: not listedNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: not listedDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “US: TN, FL, LA, VA, MI, OH, NC, WA, UT, TX, NV, AL, AR, IA, MA, CO, NY, SC, IN, KY, MO, MD, PA, CA, IL, SD, GA, MS, AZ, WV, ID, WY, VT, NM, OR, NJ, OK, KS, MN” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wyoming.

Recall timeline

FDA published this recall 58 days after the firm started it.

1. Firm started the recall: Aug 1, 202212. FDA classified it Class II: Sep 16, 202223. Published in FDA’s Enforcement Report: Sep 28, 202232022
  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-1756-2022 (August 1, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1756-2022 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