Date Initiated by Firm |
October 20, 2017 |
Create Date |
November 22, 2017 |
Recall Status1 |
Terminated 3 on October 09, 2018 |
Recall Number |
Z-0170-2018 |
Recall Event ID |
78392 |
510(K)Number |
K092482
|
Product Classification |
System, suction, lipoplasty - Product Code MUU
|
Product |
Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000.
Used for fat transfer and liposuction. |
Code Information |
Lot 12004 |
Recalling Firm/ Manufacturer |
Shippert Medical Technologies 6248 S Troy Cir Ste A Centennial CO 80111-6485
|
Manufacturer Reason for Recall |
Potential breach of sterility of the packaging.
|
FDA Determined Cause 2 |
Packaging process control |
Action |
A n Urgent: Medical Device Recall letter, dated October 20, 2017, was mailed to the user, identifying the affected device and describing the reason for the recall. The letter also provided the risk to health involved and discussed how the user can recognize the failure. Customers were instructed to remove all affected product from their inventory and quarantine them. Additionally, the letter should be forwarded to all necessary staff. Customers are to complete the Recall Response letter within 10 calendar days. Only the affected products listed should be returned per the instructions provided. Questions should be directed to Customer Service at 800-888-8663. |
Quantity in Commerce |
56 units |
Distribution |
Worldwide Distribution -- United States, Australia, and Netherlands. |
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 = MUU and Original Applicant = SHIPPERT MEDICAL TECHNOLOGIES CORP.
|