Device product
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.
Z-1740-2018
Product summary
- Event
- Event 79435
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 box of 10 tips each
- Official record key
device-enforcement:Z-1740-2018
Official wording
Reason: Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
Code information: Lot Numbers: 70208, 70209, 70210 UDI: 00811099011989
Distribution pattern: Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.
Derived failure modes
-
Sterility assurance
compromised sterile barrier