Microvention, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1221-2020)
See the recall detail below. You can also see other recalls from the same firm in 2020.
Terumo AZUR Peripheral Coil System, Detachable 18, Framing Coil, REF numbers 45-681026, 45-681434, 45-682050, and 45-680820, Sterile, Rx. The firm name on the label is MicroVention, Inc., Tustin, CA; Distributed By: Terumo Medical Corporation, Somerset, NJ; Made in Costa Rica.
Class II
The devices may be missing the implant coil.
Catalog/lot numbers: 45-681026 - 1903085J5,1903155J5, and 1904035J5; 45-681434 - 1903015J5,1903155J5, and 1904155J5; 45-682050 - 1903085K5, 1903135J5, 1903155J5, 1904015J5, 1904155J5, 1904175J5, and 1905105K5; and 45-680820 - 1903045J5, 1903085K5, 1903155J5, 1904015J5, 1904035J5, and 1904155J5.
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.
Voluntary: Firm initiated