AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
- Company
- Microvention Inc.
- Recall Initiated
- August 24, 2023
- Posted
- October 27, 2023
- Recall Number
- Z-0187-2024
- Quantity
- 14
- Firm Location
- Aliso Viejo, CA
Reason for Recall
Peripheral coil system detachable has a potential of unsealed pouch packaging.
Distribution
US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.
Lot / Code Info
UDI-DI: 00812636021089, Lot: 0000190693, Expiration: 4/30/2027
Root Cause
Process control
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
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