Terumo AZUR Peripheral Coil System, Detachable 35, Framing Coil, REF numbers 45-651026 and 45-652050, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
This recall has been terminated (originally issued November 24, 2019).
- Company
- Microvention Inc.
- Recall Initiated
- November 24, 2019
- Terminated
- April 20, 2021
- Recall Number
- Z-1224-2020
- Quantity
- 19 units
- Firm Location
- Aliso Viejo, CA
- Official Source
- View on FDA website ↗
Reason for Recall
The devices may be missing the implant coil.
Distribution
The devices were distributed to Maryland. There was no direct military/government distribution. Foreign distribution was made direct to Belgium, Japan, Australia, Argentina, and Mexico.
Lot / Code Info
Catalog/lot numbers: 45-651026 - 19030655Y, 19041556W, and 19051058A; and 45-652050 - 19030654Y and 19041556X.
Root Cause
Other
Action Taken
The recalling firm issued emails dated 11/24/2019 to the Terumo distributors and provided instructions for notification of their customers (physicians).
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