Recall Z-0470-2021 ยท MND Ligator, Esophageal
Micro-Tech Usa
Elastic Traction Device, 11mm Lower. UPN: ER56041 Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.
| Date | Oct 5, 2020 |
| Status | Terminated |
| Reason | FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US. |
| Root cause | No Marketing Application |
| Action | On October 7, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers, advising them that the firm is voluntarily recalling the Elastic Traction Device. Further distribution or use of any remaining product should cease immediately. Customers were asked to identify and quarantine devices left in inventory. They should complete the customer Acknowledgement and Receipt Form accompanying the letter and return the form to Micro-Tech Endoscopy USA. If product is available for return, the firm will contact your facility to create a Returned Material Authorization with s |
| Quantity | 2420 pieces |
| Distribution | US Nationwide distribution including in the states of AZ, CA, CO, CT, IL, MA, MI, NY, OH, PR, TX, VA. No OUS distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.