| Class 2 Device Recall Steris Small Renaissance Eagle 3000. | |
Date Initiated by Firm | March 06, 2008 |
Date Posted | September 17, 2008 |
Recall Status1 |
Terminated 3 on September 28, 2010 |
Recall Number | Z-2350-2008 |
Recall Event ID |
48999 |
510(K)Number | K964332 |
Product Classification |
Steam sterilizer - Product Code FLE
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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 OH 44060-1834
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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 | 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 |
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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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510(K) Database | 510(K)s with Product Code = FLE
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