Z-0187-2024 Class II Ongoing
FDA device recall Z-0187-2024 was initiated by MICROVENTION INC. on August 24, 2023 and is designated Class II. Reason for recall: Peripheral coil system detachable has a potential of unsealed pouch packaging. The recall status is ongoing. Affected quantity: 14.
Recall Details
- Product Type
- Devices
- Report Date
- November 8, 2023
- Initiation Date
- August 24, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14
Product Description
AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Reason for Recall
Peripheral coil system detachable has a potential of unsealed pouch packaging.
Distribution Pattern
US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.
Code Information
UDI-DI: 00812636021089, Lot: 0000190693, Expiration: 4/30/2027