Recall Z-0170-2018 ยท MUU System, Suction, Lipoplasty
Shippert Medical Technologies
Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.
| Date | Oct 20, 2017 |
| Status | Terminated |
| Reason | Potential breach of sterility of the packaging. |
| Root cause | Packaging process control |
| Action | A n Urgent: Medical Device Recall letter, dated October 20, 2017, was mailed to the user, identifying the affected device and describing the reason for the recall. The letter also provided the risk to health involved and discussed how the user can recognize the failure. Customers were instructed to remove all affected product from their inventory and quarantine them. Additionally, the letter should be forwarded to all necessary staff. Customers are to complete the Recall Response letter within 10 calendar days. Only the affected products listed should be returned per the instructions pro |
| Quantity | 56 units |
| Distribution | Worldwide Distribution -- United States, Australia, and Netherlands. |
| 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 |