Device product
LIFEPAK 35 ECG cable REF 11111-000041
Z-1102-2025
Product summary
- Event
- Event 96048
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 245 units
- Official record key
device-enforcement:Z-1102-2025
Official wording
Reason: Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
Code information: Catalog Number: 11111-000041 UDI-DI code: 00883873834596 Lot/Serial Number: 0224
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.
Derived failure modes
-
Unknown
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions