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Recall Observatory FDA recall evidence

Device product

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

Z-1755-2022

August 01, 2022

Class II

Product summary

Firm
CAREFUSION
Event
Event 90707
Status
Ongoing
Classification
Class II
Quantity
37,550
Official record key
device-enforcement:Z-1755-2022

Official wording

Reason: 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.

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

Distribution pattern: 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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.