medical Class III Updated 2018-10-10

Dannoritzer Medizintechnik GmbH & Co. KG recalls Laparoscopy Instruments Instructions For Use (IFU) for the f

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: none
View official government recall

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