Recall Z-3062-2017
Shippert Medical Technologies · initiated June 1, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and liposuction.
Codes / lots: Lot Numbers 11934, 11948, 11984, 12002, 12020, 12046, 61119, 61287, 61363, 61146.
Reason for recall
Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
FDA-determined cause: Packaging
Action taken
Customers were notified of the recall between 06/01/2017 and 06/14/2017 via FedEx letter. Instructions included remove and quarantine all affected devices, complete and return the response form, arrange for the return of affected devices, and notify any customers if further distributed.
Details
- Recall number
- Z-3062-2017
- Initiated
- June 1, 2017
- Terminated
- January 30, 2024
- Product code
- KYZ – Syringe, Irrigating (Non Dental)
- Quantity
- 5,188 units total
- Distribution
- 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.
- Recalling firm
- Shippert Medical Technologies, Centennial, CO
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3060-2017 Class II | Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and…Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | 06/01/2017Terminated |
| Z-3061-2017 Class II | Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: Intended for fat transfer and…Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | 06/01/2017Terminated |
| Z-3063-2017 Class II | Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. Product Usage: Intended for fat transfer…Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | 06/01/2017Terminated |
| Z-3064-2017 Class II | Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for fat transfer…Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | 06/01/2017Terminated |
| Z-3065-2017 Class II | Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and…Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | 06/01/2017Terminated |
| Z-3066-2017 Class II | Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and…Seal integrity of the Tissu-Trans product sterile packages cannot be assured. | 06/01/2017Terminated |