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U.S. Department of Health and Human Services

Class 2 Device Recall AMSCO 3000 Series Washer/Disinfector Model 3052

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 Class 2 Device Recall AMSCO 3000 Series Washer/Disinfector Model 3052see related information
Date Initiated by FirmDecember 20, 2018
Create DateMarch 09, 2019
Recall Status1 Terminated 3 on July 22, 2019
Recall NumberZ-0995-2019
Recall Event ID 82035
Product Classification Disinfector, medical devices - Product Code MEC
ProductAMSCO 3000 Series Washer/Disinfector Model # 3052
Code Information Serial Numbers 3602014006 3631618006 3628818009 3629518008 3633018010 3626718010 3630918008 3630918010 3617717013 3620016019 3623516006  
FEI Number 1527821
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information ContactKatie Bias
440-392-7464
Manufacturer Reason
for Recall		The software in the systems may not process the cycle originally intended. This could result in damage to the various medical devices and instruments processed in the washer/disinfector or potential for inadequate cleaning or disinfection.
FDA Determined
Cause 2		Software Manufacturing/Software Deployment
ActionUrgent Device Field Correction notification letters dated 12/20/18 were sent to customers.
Quantity in Commerce11
DistributionThe products were distributed to the following US states: AL, AR, CA, CO, FL, GA, IL, LA, MA, MD, ME, MI, NC, NJ, NM, NY, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The products were distributed to the following foreign countries: Bahrain, Brazil, Canada, China, Saudi Arabia, South Korea, and Taiwan.
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.
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