FDA recall Z-1740-2018

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.

Reason for recall

Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.

Distribution

Distributed in the following U.S. states: FL, MA, MI, OH, OK TN, and Netherlands.

Key facts

Status

Terminated

Initiation date

2017-11-01

Report date

2018-05-16

Termination date

2019-09-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Beverly, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1740-2018