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Quality & Innovation in Healthcare
 

FIELD SAFETY CORRECTIVE ACTION (FSCA) – PRODUCT RECALL 

Posted by Vygon UK  on 04-May-2018 
FIELD SAFETY CORRECTIVE ACTION (FSCA) – PRODUCT RECALL

MICRO SELDINGER KIT Product Code: G1146-057 (FSY242)   Lot/Number:  S18025037

It has been identified by the manufacturer that the product listed above may contain unsafe levels of bacterial endotoxins (Pyrogens) introduced during the manufacturing process. Bacterial endotoxins (also called pyrogenic bacteria) can activate the inflammatory process and produce fever, chills and hypotension in patients. The manufacturer has investigated the problem and has taken steps to assure this problem does not re-occur. 
 
Please find a copy of the Field Safety Notice (FSN) and the fax/email back form attached.
 

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