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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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Event Detail

Event ID 63842
Product Type Devices
Status Ongoing
Recalling Firm Applied Medical Resources Corp
City Rancho Santa Margarita
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-05
Initial Firm Notification of
Consignee or Public
E-Mail
Distribution Pattern Worldwide Distribution - USA (nationwide) and France.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Laparoscope, general&plastic surgery Used for general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments. Lot Number: 1179107 Class II Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107. 72 units Z-0644-2013
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