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Terminated

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

FDA Recall Z-1779-2019 · Posted None

Recalling FirmSkytron, Div. The KMW Group, Inc
Recall StatusTerminated
Product CodeFLE
Date Initiated2019-04-18
Date Terminated2020-04-17
Product Quantity5 units

Reason for Recall

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

Firm Action

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 [email protected], or Bob Vreeland, at 616-656-1189 or [email protected] with any questions. For after-hours support, please call 1-800-759-8766 (SKYTRON).

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution - AK, IA, MS

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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