Recall Z-1331-2019 ยท MUU System, Suction, Lipoplasty
Shippert Medical Technologies
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.
| Date | Feb 2, 2018 |
| Status | Completed |
| Reason | 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. |
| Root cause | 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 | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092482 | TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 Shippert Medical Technologies Corp., Dec 4, 2009 |