AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
FDA device recall Z-0187-2024 · posted 2023-10-27 · Open, Classified
Recall details
- Recalling firm
- MICROVENTION INC.
- Reason for recall
- Peripheral coil system detachable has a potential of unsealed pouch packaging.
- Action taken
- On 8/22/23, recall notices were mailed to customers, who were asked to do the following: 1) Stop using, quarantine, and return affected devices to the firm. 2) Complete and return the customer acknowledgement form via email to recalls@microvention.com. Inquires can be directed to customer service at 800-990-8368
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KRD
- Quantity affected
- 14
- Distribution
- US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.
- Date initiated
- 2023-08-24
- Date posted
- 2023-10-27
- Location
- Aliso Viejo, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AZUR CX Detachable 35 Coils (K151358) | MicroVention, Inc. | 2015-09-25 |