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Recall Observatory FDA recall evidence

Device product

Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and liposuction.

Z-3062-2017

June 01, 2017

Class II

Product summary

Firm
Shippert Medical Technologies
Event
Event 77518
Status
Terminated
Classification
Class II
Quantity
5,188 units total
Official record key
device-enforcement:Z-3062-2017

Official wording

Reason: Seal integrity of the Tissu-Trans product sterile packages cannot be assured.

Code information: Lot Numbers 11934, 11948, 11984, 12002, 12020, 12046, 61119, 61287, 61363, 61146.

Distribution pattern: Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, MD, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WV. and the countries of: Italy, Austria, Turkey, United Arab Emirates, Germany, Spain, Saudi Arabia, Switzerland, Japan Kuwait, Denmark, Sweden, United Kingdom, Belgium, France, Australia, Netherlands, Greece, South Korea.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Seal integrity of the Tissu-Trans product sterile packages cannot be assured.