Z-1759-2022 Class II Ongoing
FDA device recall Z-1759-2022 was initiated by CAREFUSION on August 1, 2022 and is designated Class II. 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 compromi… The recall status is ongoing. Affected quantity: 100.
Recall Details
- Product Type
- Devices
- Report Date
- September 28, 2022
- Initiation Date
- August 1, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 100
Product Description
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
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 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
Code Information
UDI-DI: 10885403237669, Lots: 22029674