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Open, Classified

AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324

FDA Recall Z-0187-2024 · Posted 2023-10-27

Recalling FirmMICROVENTION INC.
Recall StatusOpen, Classified
Product CodeKRD
Date Initiated2023-08-24
Product Quantity14

Reason for Recall

Peripheral coil system detachable has a potential of unsealed pouch packaging.

Firm Action

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 [email protected]. Inquires can be directed to customer service at 800-990-8368

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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