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U.S. Department of Health and Human Services

Class 2 Device Recall STERRAD Sterilizers

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 Class 2 Recall
STERRAD Sterilizers
see related information
Date Posted February 07, 2008
Recall Status1 Open
Recall Number Z-0844-2008
Recall Event ID 45846
Premarket Notification
510(K) Numbers
K030429  K042116  K981625  K991999 
Product Classification Sterilizer, Chemical - Product Code MLR
Product STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX Sterilizers Compatible Medical Device Reference List for NX Customers, Product Code 15-53231; STERRAD NX System Brochure, Product Code AD-53421-001, Advanced Sterilization Products, Irvine, CA
Code Information Product Codes: 15-53229 ( Revision A of the list was released 4/5/2005), 15-53230 (Revision A of the list was released 4/5/2005), 15-53231(Revision A of the list was released 4/5/2005) & AD-53421-001( Revision A of the brochure was released 1/14/2006
Recalling Firm/
Manufacturer
Advanced Sterilization Products
33 Technology Dr
Irvine, California 92618-2346
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Kevin Corrigan
949-453-6410
Manufacturer Reason
for Recall
Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Labeling Change Control
Action Notification letters, Urgent Product Correction, were sent to customers beginning on November 13, 2007 via UPS overnight. Customers were notified this action was being taken as a result of an investigation by the firm determined that all brand- and model-specific compatibility lists and associated instrument assessments provided to STERRAD Sterilization System customers are now out-of-date. User were instructed to discontinue their use and destroy them.
Quantity in Commerce 9,686 units
Distribution Worldwide: USA, France, Germany, Italy, The UK, Switzerland, Benelux,Uruguay,Venezuela,Argentina,Chile,Colombia,Ecuador,Belgium, Puerto Rico, Hong Kong,Indonesia,Mexico,Philippines,Australia,Austria,China, Greece,Ireland,Israel, Japan,Korea,Malaysia,Singapore,Taiwan,Thailand, Turkey, Middle East, Peru,Canada,The Czech Republic,Portugal,S Africa, Spain,Sweden,Hungary,Poland,Brazil,Russia,Egypt,India &Slovenia and Canada
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 = MLR and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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