Lower riskMedical device recall · FDA · Published June 9, 2021
CAREFUSION MaxPlus bi fuse extension set recall: Leakage risk in needleless connectors
CAREFUSION recalls MaxPlus bi fuse extension sets with 2 clear needleless connectors due to leakage issues in validation testing. Affected units may not meet safety standards for medical use.
“CAREFUSION MaxPlus bi fuse extension set recall: Leakage risk in needleless connectors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62365-carefusion-maxplus-bi-fuse-extension-set-recall-leakage-risk-in. Based on FDA recall #Z-1995-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1995-2021%22&limit=1).
The FDA announced on June 9, 2021, that CAREFUSION is recalling MaxPlusTM bi fuse extension sets with 2 clear needleless connectors because a validation lot was released to the U.S. market without meeting leakage testing criteria.
How to tell if you have it
MaxPlusTM bi fuse extension set with 2 clear needleless connectors
Catalog Number: MP9246-C
GTIN/UPC: 10885403237157
Lot Number: 20087194
The hazard
The product did not meet validation testing criteria regarding leakage because a portion of a validation lot was inadvertently released to the U.S. market.
Context
GovInfoNow's records show CAREFUSION has two other recalls on record since August 2, 2021. On August 1, 2022, CAREFUSION recalled BD MaxGuard Extension Sets due to label errors risking infection. On August 2, 2021, CAREFUSION recalled BD Burette Gravity Sets due to flow issues risking therapy delay. Other recent recalls of similar products include Medline ENFIT G-TUBE Connector Recall (February 13, 2026), ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026), and ICU Medical CADD Yellow Medication Cassette Reservoir Recall (August 20, 2026).
How to tell if you have this one
Check for the product name 'MaxPlus bi fuse extension set' with 2 clear needleless connectors. The affected lot number is 20087194. The product was sold with catalog number MP9246-C and GTIN 10885403237157.
Brand
CAREFUSION
Product
MaxPlusTM bi fuse extension set with 2 clear needleless connectors
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the lot number on your product label; affected units have lot number 20087194.
Where it went and when
Where it was distributed
Distributed in Tennessee.
Listed by the agency
Not listed
FDA distribution: “U.S.: TN O.U.S.: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Tennessee.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1995-2021 (June 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1995-2021 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.