Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall TissuTrans FILTRON 1000

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall TissuTrans FILTRON 1000 see related information
Date Initiated by Firm February 02, 2018
Create Date May 15, 2019
Recall Status1 Completed
Recall Number Z-1333-2019
Recall Event ID 81837
510(K)Number K092482  
Product Classification System, suction, lipoplasty - Product Code MUU
Product Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Code Information 61627, 61687, 61839, 61920, 62051, and 62087
Recalling Firm/
Manufacturer		 Shippert Medical Technologies
6248 S Troy Cir Ste A
Centennial CO 80111-6485
For Additional Information Contact Customer Service
651-789-3939
FDA Determined
Cause 2		 Packaging process control
Action Letters dated 1/9/2018 were issued beginning 2/2/2018 via registered mail and Fed Ex explaining the reason for recall, risk to health, description of how to recognize the device failed, and actions to be taken.
Quantity in Commerce 6,553 units were distributed for all catalog numbers
Distribution Distribution was nationwide, including PR. There was government/military distribution. Foreign distribution was made to Australia, Austria, Belgium, Denmark, Germany, Greece, India, Italy, Japan, Netherlands, New Zealand, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and United Kingdom,
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.
510(K) Database 510(K)s with Product Code = MUU and Original Applicant = SHIPPERT MEDICAL TECHNOLOGIES CORP.
-
-