Reported Oct 10, 2018 · Terminated
Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or…
Dannoritzer Medizintechnik GmbH & Co. KG
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dannoritzer Medizintechnik GmbH & Co. KG · Sattlerstr. 25 · Tuttlingen · N/A
Is this the product you have?
- Laparoscopy Instruments Instructions
- For Use (IFU) for the following1)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
- Lot codes and dates
- none
Where it was sold
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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