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Recall Observatory FDA recall evidence

Device product

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

Z-1779-2019

April 18, 2019

Class II

Product summary

Firm
Skytron, Div. The KMW Group, Inc
Event
Event 82650
Status
Terminated
Classification
Class II
Quantity
5 units
Official record key
device-enforcement:Z-1779-2019

Official wording

Reason: Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure

Code information: Serial Numbers: 14092619, 14092620, 14102621, 17123520, 18113521

Distribution pattern: US Nationwide Distribution - AK, IA, MS

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure