FDA recall Z-1779-2019

Skytron, Div. The KMW Group, Inc · Class II · 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

Reason for recall

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

Distribution

US Nationwide Distribution - AK, IA, MS

Key facts

Status: Terminated
Initiation date: 2019-04-18
Report date: 2019-06-19
Termination date: 2020-04-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Grand Rapids, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1779-2019