FDA Enforcement
Class II
Ongoing
AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Recall: Z-0187-2024
·
Reported November 8, 2023
Enforcement
- Recall Number
- Z-0187-2024
- Event ID
- 93147
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- MICROVENTION INC.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 8, 2023
- Initiation Date
- August 24, 2023
- Classification Date
- October 27, 2023
- Address
- 35 Enterprise, N/A, Aliso Viejo, CA, 92656, United States
Description
AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Reason
Peripheral coil system detachable has a potential of unsealed pouch packaging.
Code Info
UDI-DI: 00812636021089, Lot: 0000190693, Expiration: 4/30/2027
Distribution
US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.
Quantity
14