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U.S. Department of Health and Human Services

Class 2 Device Recall AMSCO 5000 Series Washer/Disinfector Model 5052

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  Class 2 Device Recall AMSCO 5000 Series Washer/Disinfector Model 5052 see related information
Date Initiated by Firm December 20, 2018
Create Date March 09, 2019
Recall Status1 Terminated 3 on July 22, 2019
Recall Number Z-0996-2019
Recall Event ID 82035
Product Classification Disinfector, medical devices - Product Code MEC
Product AMSCO 5000 Series Washer/Disinfector Model # 5052
Code Information Serial Numbers 3627418005 3601518006 3612718013 3633817009 3632318011 3626718014 3625114008 3600515028 3600515029 3600515030 3628516022 3626718013 3631618008 3627418007 3624514006 3628818001 3608518007 3634517006 3630218008 3605316016 3600917004 3628218007 3628818003 3629518009 3626718009 3626718011 3627418001 3627418002 3630218012 3630218013 3630918013 3632318012 3626718016 3634517005 3631414004 3603618005 3607217008 3630318013 3626817008 3628317012 3616615026 3630918014 3633018006 3628218009 3632318009 3628218011 3623615011A 3601518012 3612817007 3627418009 3628218006 3627418008 3631618007 3617315011 3614818009 3624017008 3629215012 3614516007 3628218010 3610216025 3634313010 3611715016 3628818005 3615617008 3624017009 3616516020 3627418004 3627418006  
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Katie 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
Action Urgent Device Field Correction notification letters dated 12/20/18 were sent to customers.
Quantity in Commerce 68
Distribution The 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 Cycle TPLC 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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