Z-3062-2017 Class II Terminated
FDA device recall Z-3062-2017 was initiated by Shippert Medical Technologies on June 1, 2017 and is designated Class II. Reason for recall: Seal integrity of the Tissu-Trans product sterile packages cannot be assured. The recall status is terminated (terminated January 30, 2024). Affected quantity: 5,188 units total.
Recall Details
- Product Type
- Devices
- Report Date
- August 30, 2017
- Initiation Date
- June 1, 2017
- Termination Date
- January 30, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,188 units total
Product Description
Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and liposuction.
Reason for Recall
Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
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.
Code Information
Lot Numbers 11934, 11948, 11984, 12002, 12020, 12046, 61119, 61287, 61363, 61146.