Z-1224-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 19, 2020
- Initiation Date
- November 24, 2019
- Termination Date
- April 20, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 units
Product Description
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.
Reason for Recall
The devices may be missing the implant coil.
Distribution Pattern
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.
Code Information
Catalog/lot numbers: 45-651026 - 19030655Y, 19041556W, and 19051058A; and 45-652050 - 19030654Y and 19041556X.