FDA recall Z-2280-2019

Codman & Shurtleff Inc · Class II · device

Product

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

Reason for recall

Incorrect coil length on the label

Distribution

Japan

Key facts

Status
Terminated
Initiation date
2019-05-16
Report date
2019-08-21
Termination date
2020-06-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2280-2019