Recall Z-1779-2019— Skytron, Div. The KMW Group, Inc
Class II · Terminated
Class II FDA medical device recall by Skytron, Div. The KMW Group, Inc, initiated 2019-04-18, terminated 2020-04-17. It names one FDA 510(k) clearance: K132439. 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: Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure.
- Recalling firm
- Skytron, Div. The KMW Group, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-18
- Terminated
- 2020-04-17
- Firm location
- Grand Rapids, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.