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Microvention, Inc. recalls Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 4
Recalled February 19, 2020 · FDA recall Z-1225-2020 · Microvention
Hazard
The devices may be missing the implant coil. · FDA Class II
Units
1,187 units
Sold at
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.
Description
The devices may be missing the implant coil.
Product
Terumo AZUR CX Peripheral Coil System, Detachable 35, CX Coil, REF numbers 45-751019, 45-751324, 45-751632, 45-752039, 45-750407, 45-750511, 45-750617, 45-750609, 45-750812, 45-750824, MV-AX50407CD, MV-AX50511CD, MV-AX50617CD, MV-AX50824CD, and MV-AX51019CD, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
Manufacturer(s)
Microvention, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →