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Class 2 Device Recall TissuTrans FILTRON 250 |
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Date Initiated by Firm |
February 02, 2018 |
Create Date |
May 15, 2019 |
Recall Status1 |
Completed |
Recall Number |
Z-1331-2019 |
Recall Event ID |
81837 |
510(K)Number |
K092482
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Product Classification |
System, suction, lipoplasty - Product Code MUU
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Product |
Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO. |
Code Information |
Lot numbers 61507, 61578, 61682, 61689, 61849, 61879, 62011, 62088, and 62108 |
Recalling Firm/ Manufacturer |
Shippert Medical Technologies 6248 S Troy Cir Ste A Centennial CO 80111-6485
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For Additional Information Contact |
Customer Service 651-789-3939
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Manufacturer Reason for Recall |
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
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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
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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.
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510(K) Database |
510(K)s with Product Code = MUU and Original Applicant = SHIPPERT MEDICAL TECHNOLOGIES CORP.
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