Date Initiated by Firm |
May 16, 2019 |
Create Date |
August 15, 2019 |
Recall Status1 |
Terminated 3 on June 04, 2020 |
Recall Number |
Z-2280-2019 |
Recall Event ID |
83502 |
510(K)Number |
K171862
|
Product Classification |
Device, neurovascular embolization - Product Code HCG
|
Product |
GALAXY G3 Mini Microcoil Delivery System Product No: GLM915030 (3 cm). |
Code Information |
Lot/Serial No: L14364 UDI:10886704080138 |
Recalling Firm/ Manufacturer |
Codman & Shurtleff Inc 47709 Fremont Blvd Fremont CA 94538-6512
|
For Additional Information Contact |
Yolanda Bolanos 954-643-7081
|
Manufacturer Reason for Recall |
Incorrect coil length on the label
|
FDA Determined Cause 2 |
Error in labeling |
Action |
Sales 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. |
Quantity in Commerce |
28 units |
Distribution |
Japan |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = HCG and Original Applicant = Codman & Shurtleff, Inc
|