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FDAFDA · Food and drugs·Recall number Z-1756-2022

BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436

Published September 28, 2022 · Recall initiated: August 1, 2022

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the 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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
CAREFUSION
Distributor
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
Lot
UDI-DI: 10885403237478, Lots: 22019074, 22019431, 22019075, 22019076
Risk classification
Class II
Area (FDA)
device
Country
United States

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