CAREFUSION: Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 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.

Agency Publication Date: September 13, 2022

Affected Products

Product: BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433

UDI-DI: 10885403237782, Lots: 22019085

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

Product: BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059

UDI-DI: 10885403237584, Lots: 22029431, 22029432

Product: BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166

UDI-DI: 10885403237652, Lots: 22029648

Product: BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171

UDI-DI: 10885403237669, Lots: 22029674

Product: BD MaxGuard Extension Set with 4-way stopcock, REF: M4058

UDI-DI: 10885403235788, Lots: 22019324, 22019323, 22019322

Product: BD MaxGuard Extension Set, REF: ME1069

UDI-DI: 10885403236037, Lots: 22019062

Product: BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106

UDI-DI: 10885403236358, Lots: 22019311, 22019312, 22019313, 22019314

Product: BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141

UDI-DI: 10885403236471, Lots: 22029167, 22029168, 22029169

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90707

Status: Active

Manufacturer: CAREFUSION

Manufactured In: United States

Units Affected: 9 products (46,900; 3,500; 54,050; 37,550; 19,925; 17,250; 600; 100; 9,900)

Agency Last Updated: September 16, 2022

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.