Microline Surgical, Inc. recalls ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use dis…

Recall date

November 1, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1740-2018

FDA classification

Class II

Brand / firm

Microline Surgical, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.