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U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD 50 Sterilizer

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  Class 2 Device Recall STERRAD 50 Sterilizer see related information
Date Initiated by Firm November 12, 2007
Date Posted February 08, 2008
Recall Status1 Terminated 3 on March 14, 2012
Recall Number Z-0846-2008
Recall Event ID 45851
Product Classification Sterilizer - Product Code MLR
Product STERRAD 50 Sterilizer, Product Code:10050, Advanced Sterilization Products, Irvine, CA
Code Information All Serial Numbers
Recalling Firm/
Manufacturer		 Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information Contact Kevin Corrigan
949-453-6410
Manufacturer Reason
for Recall		 User Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization and subsequent light colored residue on these devices after sterilization updated user guidance has been issued.
FDA Determined
Cause 2		 Employee error
Action Urgent Product Correction letters were sent to customers beginning on November 13, 2007 via UPS overnight. Customers were notified this action was being taken to clarify instructions contained within the STERRAD System User Guides to reinforce appropriate use and to address two separate issues which have arisen from user reports: (1) User reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization. (2) User reports about light-colored residues observed on instruments, trays and pouches after sterilization. The Product Correction Letters instructed customers to refer to the revised excerpt of the User Guide (attached to the letter) for information about instrument preparation prior to sterilization, particularly with regard to the washing, rinsing and thorough drying of instruments prior to sterilization in the STERRAD Sterilization System. If customers have any questions they were instructed to call ASP Customer Care Center to answer additional questions at (888) 783-7723.
Quantity in Commerce 9,686 units total for recalls Z-0845-0848-2008
Distribution Worldwide: USA, France, Germany, Italy, The UK, Switzerland, Benelux, Uruguay, Venezuela, Argentina, Chile, Colombia, Ecuador, Belgium, Puerto Rico, Hong Kong, Indonesia, Mexico, The Philippines, Switzerland, Australia, Austria, China, Greece, Ireland, Israel, Japan, Korea, Malaysia, Singapore, Taiwan, Thailand, Turkey, Middle East, Peru, Canada, The Czech Republic, Middle East, Portugal, S Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India & Slovenia
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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