FDA-Device2019-06-19Class II
Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry
Skytron, Div. The KMW Group, Inc
Hazard
Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure
Sold states
US Nationwide Distribution - AK, IA, MS
Affected count
5 units
Manufactured in
5085 Corporate Exchange Blvd SE, N/A, Grand Rapids, MI, United States
Products
Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam Sterilizer for use in health care facilities. The Integrity Sterilizer incorporates high-pressure steam to sterilize nonporous or porous items and materials used in the health care industry
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1779-2019Don't want to check this manually?
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