RecallDepth

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).

More recalls by Skytron, Div. The Kmw Group, Inc

View all recalls by this company →