Z-1779-2019 Class II Terminated
FDA device recall Z-1779-2019 was initiated by Skytron, Div. The KMW Group, Inc on April 18, 2019 and is designated Class II. Reason for recall: Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure The recall status is terminated (terminated April 17, 2020). Affected quantity: 5 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 19, 2019
- Initiation Date
- April 18, 2019
- Termination Date
- April 17, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 units
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
Distribution Pattern
US Nationwide Distribution - AK, IA, MS
Code Information
Serial Numbers: 14092619, 14092620, 14102621, 17123520, 18113521