High FDA (Devices)·Z-1779-2019·Announced 2019-06-19

Skytron Integrity 270 Steam Sterilizer Recalled for Weld Fatigue

Skytron is recalling five Integrity 270 Steam Sterilizers because the weld attaching the air heater assembly has shown signs of fatigue or failure.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect (weld fatigue) in a medical device used for sterilization. While no injuries or illnesses are reported, the potential for failure of a high-pressure steam sterilizer presents a risk of harm, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Skytron, Div. The KMW Group, Inc. is recalling five units of the Skytron Integrity 270 Steam Sterilizer and Skytron Integrity 270VP Steam Sterilizer. These devices are used in health care facilities to sterilize nonporous or porous items and materials using high-pressure steam.

The recall was initiated because the weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue or failure. The affected units were distributed nationwide in the United States, specifically in Alaska, Iowa, and Mississippi.

Health care facilities should identify the affected units by checking for the following serial numbers: 14092619, 14092620, 14102621, 17123520, and 18113521. Facilities should contact Skytron for instructions on how to proceed with the recall.

The recalled product

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
Manufacturer: Skytron, Div. The KMW Group, Inc
Category: Medical Device — Sterilizer
Hazard: structural-failure
weld-fatigue
Affected units: 5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

Serial Numbers: 14092619
14092620
14102621
17123520
18113521

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Same manufacturer · Skytron, Div. The KMW Group, Inc

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