FDA-Device2020-02-19Class II
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.
Microvention, Inc.
Hazard
The devices may be missing the implant coil.
Sold states
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.
Affected count
19 units
Manufactured in
35 Enterprise, Aliso Viejo, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1224-2020Don't want to check this manually?
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