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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Applied Medical Kii Optical Access System		see related information
Date Posted September 18, 2009
Recall Number Z-2226-2009
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
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.
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.
 
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