Recall Z-1698-2019 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Microline Surgical, Inc.
TLS2 Thermal Ligating Shears, Catalog Number 132-131D
| Date | Mar 22, 2019 |
| Status | Terminated |
| Reason | The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall letters dated 3/22/19 were sent to customers. |
| Quantity | 115 units |
| Distribution | The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062257 | STARION INSTRUMENTS THERMAL LITIGATING SHEARS Starion Instruments, Oct 10, 2006 |