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FDA (Device enforcement)Recalled 2022-08-01class ii

CAREFUSION: BD MaxGuard Extension Set, REF: ME1069

Is my product affected?

BD MaxGuard Extension Set, REF: ME1069

  • UPC 10885403236037

Check against the official notice below — it lists the full affected range.

What happened

CareFusion has recalled approximately 3,500 BD MaxGuard Extension Sets (Reference ME1069) distributed across 39 U.S. states because the product labels incorrectly list an expiration year of 2027 when the actual expiration year is 2025. The affected lots are identified by UDI-DI 10885403236037 and lot number 22019062. If expired product is used, the integrity of the product may be compromised, potentially resulting in leaks and creating a risk of infection to both patients and healthcare workers.

The recall notice does not specify a remedy or action that affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. 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 Quantity: 3,500 Lot/code info: UDI-DI: 10885403236037, Lots: 22019062

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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