Device product
AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Z-0187-2024
Product summary
- Event
- Event 93147
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14
- Official record key
device-enforcement:Z-0187-2024
Official wording
Reason: Peripheral coil system detachable has a potential of unsealed pouch packaging.
Code information: UDI-DI: 00812636021089, Lot: 0000190693, Expiration: 4/30/2027
Distribution pattern: US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.
Derived failure modes
-
Labeling or packaging
unsealed pouch