Dannoritzer Laparoscopy Instruments IFU Recalled for Unvalidated Cleaning Instructions
Dannoritzer Medizintechnik GmbH & Co. KG is recalling Instructions For Use (IFU) for certain laparoscopy instruments because the manual cleaning process was not validated.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a documentation and validation error regarding cleaning instructions, not a direct product defect causing injury.
Plain-English summary
Dannoritzer Medizintechnik GmbH & Co. KG is recalling Instructions For Use (IFU) for specific laparoscopy instruments, including monopolar electrodes, modular forceps or scissors components, and one-piece forceps or scissors for electrosurgical coagulation. The recall is due to the fact that the manual cleaning process and the usability of the reprocessing instructions had not been validated.
The affected products were distributed in the United States in the states of Ohio, Michigan, Massachusetts, California, Oklahoma, Tennessee, Georgia, Florida, Illinois, North Carolina, Texas, and Missouri. The Instructions For Use have been modified to remove the manual cleaning method and to revise the instructions for clarity and readability.
Healthcare facilities and users should stop using the affected Instructions For Use and contact the recalling firm for revised documentation. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- 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
- Manufacturer
- Dannoritzer Medizintechnik GmbH & Co. KG
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- none
Distribution
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