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U.S. Department of Health and Human Services

Class 2 Device Recall AMSCO C and AMSCO 400 Steam Sterilizers

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  Class 2 Device Recall AMSCO C and AMSCO 400 Steam Sterilizers see related information
Date Initiated by Firm February 19, 2015
Date Posted April 30, 2015
Recall Status1 Terminated 3 on January 20, 2016
Recall Number Z-1561-2015
Recall Event ID 70938
510(K)Number K112055  K111223  
Product Classification Sterilizer, steam - Product Code FLE
Product AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation.

AMSCO C Small Sterilizer, AMSCO 400 Small Sterilizer, AMSCO 400 Medium Sterilizer.

Designed for sterilization of heat and moisture-stable materials used in healthcare facilities.
Code Information AMSCO 400 Units: Serial #'s: 030051501 - 033641440; AMSCO C Units: Serial #'s: R020051501 - R023641403.
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact Ms. Kathryn E. Cadorette
440-392-7231
Manufacturer Reason
for Recall		 STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. This may result in a procedure delay.
FDA Determined
Cause 2		 Software design (manufacturing process)
Action On 3/9/2015, the firm sent Urgent Field Correction Notices, to their customers. The letter identified the affected product and gave a description of the problem. The letter states that the control software is being revised to ensure the utility shutdown feature will not interrupt an ongoing processing cycle. STERIS Field Representatives will contact customers to schedule installation of the new control board on affected units. Customers may direct questions regarding the issue to STERIS Customer Service at 1-800-548-4873; Marie LaFrance, Product Manager, at 440-392-7648, or their local sales representative.
Quantity in Commerce 701 units
Distribution Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, I, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY; and, the countries of Afghanistan, Canada, Japan, Kuwait, Mexico, Republic of Korea, & United Arab Emirates.
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.
510(K) Database 510(K)s with Product Code = FLE and Original Applicant = STERIS Corporation
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