Z-1102-2025 Class II Ongoing
FDA device recall Z-1102-2025 was initiated by Physio-Control, Inc. on January 21, 2025 and is designated Class II. Reason for recall: Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions The recall status is ongoing. Affected quantity: 245 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2025
- Initiation Date
- January 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 245 units
Product Description
LIFEPAK 35 ECG cable REF 11111-000041
Reason for Recall
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
Distribution Pattern
U.S. Nationwide distribution in the states of CA, FL, GA, IA, IN, KY, MD, MI, MO, NE, NV, NY, OH, OR, SC, TN, TX, and WI.
Code Information
Catalog Number: 11111-000041 UDI-DI code: 00883873834596 Lot/Serial Number: 0224