FDAFDA · Food and drugs·Recall number Z-1760-2022
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
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: 10885403237782, Lots: 22019085
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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