FDAFDA · Food and drugs·Recall number Z-1225-2020
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.
Published February 19, 2020 · Recall initiated: November 24, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The devices may be missing the implant coil.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Microvention, Inc.
- Distributor
- 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
- Catalog/lot numbers: 45-751019 - 1903045J2, 1903065J2, 1903085J2, 1904155J2, 1904175J2, 1904265J2, 1904295J2, 1905035J2, 1905085J2, 1905105K2, and 1905135J2; 45-751324 - 1903045J2, 1903155J2, 1903205J2, 1903225J2, 1904155J2, 1904225J2, 1904265J2, 1904295J2, 1905065J2, and 1905085J2; 45-751632 - 1903045J2, 1903065J2, 1903205J2, 1903225J2, 1904175J2, 1904265J2, 1904295J2, 1905035J2, 1905065J2, and 1905085J2; 45-752039 - 1903045J2, 1903205J2, 1904265J2, 1905035J2, and 1905065J2; 45-750407 - 1903045J2, 1903065J2, 1903085J2, 1903115J2, 1903155J2, 1904175J2, 1904175K2, 1904225J2, 1904245J2, 1904265J2, and1904295J2 45-750511 - 1903045J2, 1903065J2, 1903085J2, 1903155J2, 1904175J2, 1904175K2, 1904225J2, 1904245J2, 1904265J2, 1904295J2; 45-750617 - 1903045J2, 1903065J2, 1903085J2, 1903155J2, 1904055J2, 1905035J2, 1905065J2, and 1905085J2; 45-750609 - 1903045J2, 1903065J2, 1903085J2, and 1904035J2; 45-750812 - 1903045J2, 1903085J2, 1905035J2, 1905065J2, and 1905085J2; 45-750824 - 1903045J2, 1903065J2, 1903155J2 ,1904055J2, 1905035J2, 1905065J2, and 1905085J2; MV-AX50407CD - 1904015J9, 1904035J9, and 1904085J9; MV-AX50511CD - 1904015J9, 1904035J9, and 1904055J9; MV-AX50617CD - 1904015J9 and 1904035J9; MV-AX50824CD - 1904015J9 and 1904035J9; and MV-AX51019CD - 1905105J9.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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