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U.S. Department of Health and Human Services

Class 2 Device Recall Steam Sterilizer

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 Class 2 Device Recall Steam Sterilizersee related information
Date Initiated by FirmApril 18, 2019
Create DateJune 13, 2019
Recall Status1 Terminated 3 on April 17, 2020
Recall NumberZ-1779-2019
Recall Event ID 82650
510(K)NumberK132439 
Product Classification Sterilizer, steam - Product Code FLE
ProductSkytron 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
Code Information Serial Numbers: 14092619, 14092620, 14102621, 17123520, 18113521
FEI Number 1825014
Recalling Firm/
Manufacturer		 Skytron, Div. The KMW Group, Inc
5085 Corporate Exchange Blvd SE
Grand Rapids MI 49512-5515
For Additional Information Contact
616-656-2900
Manufacturer Reason
for Recall		Weld attaching the air heater assembly to the main sterilizer unit has shown signs of fatigue/failure
FDA Determined
Cause 2		Device Design
ActionSkytron 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 www.lperez@skytron.us, or Bob Vreeland, at 616-656-1189 or www.bvreeland@skytron.us with any questions. For after-hours support, please call 1-800-759-8766 (SKYTRON).
Quantity in Commerce5 units
DistributionUS Nationwide Distribution - AK, IA, MS
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = FLE
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