Z-0062-2019 Class III Terminated
FDA device recall Z-0062-2019 was initiated by Dannoritzer Medizintechnik GmbH & Co. KG on August 6, 2018 and is designated Class III. Reason for recall: 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 instruction… The recall status is terminated (terminated July 22, 2019).
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2018
- Initiation Date
- August 6, 2018
- Termination Date
- July 22, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
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
Reason for Recall
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.
Distribution Pattern
US Nationwide in the States of OH, MI, MA, CA, OK, TN, GA, FL, IL, NC, TX, MO.
Code Information
none