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Class 2 Device Recall STERRAD Sterilizers |
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Date Initiated by Firm |
November 12, 2007 |
Date Posted |
February 07, 2008 |
Recall Status1 |
Terminated 3 on December 19, 2011 |
Recall Number |
Z-0844-2008 |
Recall Event ID |
45846 |
510(K)Number |
K042116 K030429 K981625 K991999
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Product Classification |
Sterilizers - Product Code MLR
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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
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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 CA 92618-2346
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For Additional Information Contact |
Kevin Corrigan 949-453-6410
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Manufacturer Reason for Recall |
Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities
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FDA Determined Cause 2 |
Other |
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compatibility lists and associated instrument assessments provided to STERRAD Sterilization System customers are now out-of-date.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
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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 = MLR and Original Applicant = ADVANCED STERILIZATION PRODUCTS
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