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U.S. Department of Health and Human Services

Class 2 Device Recall Applied Medical Kii Optical Access System

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 Class 2 Recall
Applied Medical Kii Optical Access System
see related information
Date Posted September 18, 2009
Recall Status1 Open
Recall Number Z-2226-2009
Recall Event ID 52774
Premarket Notification
510(K) Number
K060096 
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile. Disposable single-use devices indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgeries. Endoscopic instruments for surgery.
Code Information Model Number: C0R36, Lot Numbers:1084426 and 1085506.
Recalling Firm/
Manufacturer
Applied Medical Resources Corp
22872 Avenida Empresa # 3
Rancho Santa Margarita, California 92688-2650
Manufacturer Reason
for Recall
Applied Medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in tip breakage.
FDA Determined
Cause 2
DESIGN: Component Design/Selection
Action Applied Medical Resources Corp. notified Customers via an overnight "Voluntary Recall Notification" Letter dated June 9, 2009. The letter informed customers of the reason for recall and asked that the listed product be returned. The recall letter provided customers with a contact and telephone number for product return questions (1-949-713-8652) and a separate contact for regulatory questions (1-949-713-8369).
Quantity in Commerce 934 units
Distribution Class II Recall - Worldwide -- United States, Australia, New Zealand, France, Canada, Norway and Great Britain.
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 = GCJ and Original Applicant = APPLIED MEDICAL RESOURCES CORP.
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