medical Class II Updated 2020-02-19

Microvention, Inc. recalls Terumo AZUR Peripheral Coil System, Detachable 35, Framing C

Recalled Product

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.

Hazard / Issue

The devices may be missing the implant coil.

Issued by

FDA

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.

View official government recall

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