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U.S. Department of Health and Human Services

Class 2 Device Recall Steris Small Renaissance Eagle 3000.

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 Class 2 Recall
Steris Small Renaissance Eagle 3000.
see related information
Date Posted September 17, 2008
Recall Status1 Terminated on September 28, 2010
Recall Number Z-2350-2008
Recall Event ID 48999
Premarket Notification
510(K) Number
K964332 
Product Classification Sterilizer, Steam - Product Code FLE
Product Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011 and 3021 and Prevacuum Models 3013 and 3023. Products are designed for efficient sterilization of non-porous and porous, heat and moisture-stable materials used in healthcare facilities.
Code Information Gravity Models 3011 & 3021 and Prevaccuum Models 3013 and 3023.
Recalling Firm/
Manufacturer
Steris Corp
5960 Heisley Rd
Mentor, Ohio 44060-1834
For Additional Information Contact Holly Wright Lee
440-392-7019
Manufacturer Reason
for Recall
The firm discovered that some Eagle 3000 units may have a door post pin missing which could cause incomplete or no engagement of the radial arms into the lock rails of the door. The sterilizer is designed with switches that prevent cycle initiation if the door is not locked. However, in the event the door switches are not properly adjusted they may falsely indicate that the door is locked even t
FDA Determined
Cause 2
TRAINING: Employee Error
Action On March 5, 2008, Steris issued an Urgent Product Correction. Beginning March 6, 2008 customers were notified by telephone. The firm instructed their customers to immediately discontinue using the small Renaissance Eagle 3000 steam sterilizer(s) until inspected and corrected by a service technician. Steris Service technicians were dispatched to affected customers to inspect and correct the sterilizers as appropriate. If you have any questions contact Holly Wright Lee at (404) 392-7019 or 1-800-548-4873 ext. 27019.
Quantity in Commerce 148 units
Distribution Class II Recall - Worldwide Distribution --- USA including states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, LA, MD, MI, MN, MO, MT, NC, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WI, and WY, and countries of Canada and Mexico.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FLE and Original Applicant = AMSCO INTL., INC.
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