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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Skytron, Div. The KMW Group, Inc
- Category
- Medical Device — Sterilizer
- 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
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