| 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 |
| FEI Number |
3013875781
|
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
|
|---|
