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U.S. Department of Health and Human Services

Class 2 Device Recall Kii Shielded Bladed Access System

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 Class 2 Recall
Kii Shielded Bladed Access System
see related information
Date Posted January 07, 2013
Recall Status1 Terminated on January 16, 2013
Recall Number Z-0644-2013
Recall Event ID 63842
Premarket Notification
510(K) Number
K072674 
Product Classification Radioimmunoassay, Follicle-Stimulating Hormone - Product Code CGJ
Product 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.
Code Information Lot Number: 1179107
Recalling Firm/
Manufacturer
Applied Medical Resources Corp
22872 Avenida Empresa # 3
Rancho Santa Margarita, California 92688-2650
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Chris Stolrow
949-713-8662
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Applied Medical sent an Urgent Medical Device Recall to all affected customers in November 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete the attached Recall Notification Confirmation Form to acknowledge the recall and indcated any product their facility is returning. The Recall confirmation form should be returned to Applied Medical by emailing to recall60494844#applied medical.com or fax to 949-713-8832. Return affecte4d product and a copy of the confirmation form to Applied Medical. Customers with questions were instructed to call 949-713-8662. For questions regarding this recall 949-713-8662.
Quantity in Commerce 72 units
Distribution Worldwide Distribution - USA (nationwide) and France.
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 = CGJ and Original Applicant = APPLIED MEDICAL RESOURCES CORP.
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