PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 19, 2019 Initiated: April 18, 2019 #Z-1779-2019

Product Description

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

Reason for Recall

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

Details

Units Affected
5 units
Distribution
US Nationwide Distribution - AK, IA, MS
Location
Grand Rapids, MI

Frequently Asked Questions

What product was recalled?
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. Recalled by Skytron, Div. The KMW Group, Inc. Units affected: 5 units.
Why was this product recalled?
Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure
Which agency issued this recall?
This recall was issued by the FDA Devices on June 19, 2019. Severity: Moderate. Recall number: Z-1779-2019.