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Lumenis VersaCut Morcellator Recalled Due to Incorrect Label Which, When Followed, May Cause Deadly Air Embolisms During Surgery


Certain models of VersaCut Morcellator devices have been recalled to correct their labeling. There is a potential for air embolisms to occur if the aspiration tubing is hooked up backwards to the aspiration control box housing, as indicated on the incorrect label. The VersaCut Morcellator breaks up and removes dissected tissue during surgical procedures when access to the surgical site is limited.

 

The affected model numbers are 0637-245-01 (starter kit) and 0636-470-01 (Control Box). Of these model numbers all products manufactured since May 1998 are affected. Lumenis placed an immediate internal quarantine on all affected products within its possession. The firm will re-label these devices and replace the current Operator's Manual with the revised Manual.

 

Lumenis sent an Urgent Safety Advisory Notice letter to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to re-label the device with the two labels provided and remove and destroy the existing Operator’s Manual and replace it with the current revised Manual.

 

The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

 

See the Recall

 

 

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