Z-1740-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 16, 2018
- Initiation Date
- November 1, 2017
- Termination Date
- September 17, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 box of 10 tips each
Product Description
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.
Reason for Recall
Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.
Distribution Pattern
Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.
Code Information
Lot Numbers: 70208, 70209, 70210 UDI: 00811099011989