Recall Z-0507-2018 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Microline Surgical, Inc.
The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
| Date | Jul 13, 2017 |
| Status | Terminated |
| Reason | The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure. |
| Root cause | Device Design |
| Action | The firm, Microline Surgical, Inc., sent a "URGENT: MEDICAL DEVICE RECALL" letter dated July 13, 2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately determine if you are in possession of the product and stop use; quarantine all products both new un-opened Reusable Tips AND Reusable Tips that have been used or are in current use (regardless of whether you have observed the malfunction); If you are a distributor or further distributed this product, we require that you immediately remove affected products from inve |
| Quantity | 61,769 units |
| Distribution | Worldwide Distribution-US (Nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, El Salvador, Hong Kong, India, Indonesia, Malaysia, Mexico, Panama, Peru, Argentina, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay & Vietnam. |
| FDA record | Open on fda.gov |