Dannoritzer Medizintechnik GmbH & Co. KG recalls Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or s…

Recall date

August 6, 2018

Source

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

Recall number

Z-0062-2019

FDA classification

Class III

Brand / firm

Dannoritzer Medizintechnik GmbH & Co. KG

Sold / distributed

US Nationwide in the States of OH, MI, MA, CA, OK, TN, GA, FL, IL, NC, TX, MO.

Why it was recalled

The Manual cleaning process and the usability of the reprocessing instruction by the user had not been validated. The IFU was modified to remove the manual cleaning method and revised the instructions for use for clarity and readability.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation