FDAFDA · Food and drugs·Recall number Z-1779-2019
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
Published June 19, 2019 · Recall initiated: April 18, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Skytron, Div. The KMW Group, Inc
- Distributor
- US Nationwide Distribution - AK, IA, MS
- Lot
- Serial Numbers: 14092619, 14092620, 14102621, 17123520, 18113521
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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