ClearanceBrief
Recall Z-2280-2019 ยท HCG Device, Neurovascular Embolization

Codman & Shurtleff Inc

GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm).

DateMay 16, 2019
StatusTerminated
ReasonIncorrect coil length on the label
Root causeError in labeling
ActionSales representatives will communicate the action to be taken with respect to this recall. If you have additional questions about this action, please contact y0ur local customer service.
Quantity28 units
DistributionJapan
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K171862GALAXY G3 Mini Microcoil Delivery System
Codman & Shurtleff, Inc., Sep 25, 2017