Z-1740-2018 Class II Terminated

Recalled by Microline Surgical, Inc. — Beverly, MA

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