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U.S. Department of Health and Human Services

Class 2 Device Recall TissuTrans FILTRON 500

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 Class 2 Device Recall TissuTrans FILTRON 500see related information
Date Initiated by FirmFebruary 02, 2018
Create DateMay 15, 2019
Recall Status1 Completed
Recall NumberZ-1332-2019
Recall Event ID 81837
510(K)NumberK092482 
Product Classification System, suction, lipoplasty - Product Code MUU
ProductTissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologies, Centennial, CO.
Code Information Lot numbers 61508, 61636, 61683, 61753, 61804, 61812, 61813, 61814, 61815, 61862, 61917, 61949, 61991, 62052, 62089, 62134, and 62156
FEI Number 3008719017
Recalling Firm/
Manufacturer		 Shippert Medical Technologies
6248 S Troy Cir Ste A
Centennial CO 80111-6485
For Additional Information ContactCustomer Service
651-789-3939
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.
FDA Determined
Cause 2		Packaging process control
ActionLetters 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 Commerce6,553 units were distributed for all catalog numbers
DistributionDistribution 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 CycleTPLC 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) Database510(K)s with Product Code = MUU
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