Recall Z-1740-2018 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Microline Surgical, Inc.
ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
| Date | Nov 1, 2017 |
| Status | Terminated |
| Reason | Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier. |
| Root cause | Process control |
| Action | Microline Surgical sent an Urgent Medical Device Recall letter dated November 1, 2017. Actions to be taken by the Customer/User: Please locate those products you have, quarantine them, and arrange for their return by contacting Microline Customer Service to receive an RMA number. Alternatively, you may wish to contact your Microline Distributor or Sales Representative to help with this. If you have used some or all of the identified product, please provide the item number, lot number, and the amount used so that we can track the progress of the recall. T To date, we have no evidence to sugge |
| Quantity | 12 box of 10 tips each |
| Distribution | Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981389 | DISPOSABLE RE-NEW FORCEPS Microline Pentax, Inc., May 29, 1998 |