Medical device recalls Moderate risk

Skytron, Div. The KMW Group, Inc recalls Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Product Usage: The SKYTRON Integrity 270 Steam…

Recall date
April 18, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1779-2019
FDA classification
Class II
Brand / firm
Skytron, Div. The KMW Group, Inc
Sold / distributed
US Nationwide Distribution - AK, IA, MS

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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