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
- Company
- Skytron, Div. The Kmw Group, Inc
- Recall Initiated
- April 18, 2019
- Terminated
- April 17, 2020
- Recall Number
- Z-1779-2019
- Quantity
- 5 units
- Firm Location
- Grand Rapids, MI
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
Lot / Code Info
Serial Numbers: 14092619, 14092620, 14102621, 17123520, 18113521
Root Cause
Device Design
Action Taken
Skytron issued Medical Device Correction letter on 4/18/19 via certified mail stating: reason for recall, action to be taken and will replace the air heater assembly on the affected devices. Contact Larry Perez, Vice President of Technical Services, at 616-656-2900 or www.lperez@skytron.us, or Bob Vreeland, at 616-656-1189 or www.bvreeland@skytron.us with any questions. For after-hours support, please call 1-800-759-8766 (SKYTRON).
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