Device product
BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
Z-1757-2022
Product summary
- Firm
- CAREFUSION
- Event
- Event 90707
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17,250
- Official record key
device-enforcement:Z-1757-2022
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: 10885403237584, Lots: 22029431, 22029432
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
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.