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U.S. Department of Health and Human Services

Class 2 Device Recall Applied GelPort Laparoscopic Hand Access Device, Model C8004

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  Class 2 Device Recall Applied GelPort Laparoscopic Hand Access Device, Model C8004 see related information
Date Initiated by Firm October 17, 2005
Date Posted November 16, 2005
Recall Status1 Terminated 3 on April 24, 2008
Recall Number Z-0151-06
Recall Event ID 33856
510(K)Number K003871  
Product Classification Laparoscope, General & Plastic Surgery - Product Code GCJ
Product The Applied GelPort Hand Access Device consists of a GelSeal Cap, Wound retractor (base). Standard Wound Protecting Sheath, Long Wound Protecting Sheath. Impervious Sleeve, Skin Marker. Sterile Lubricant, and Incision Template.
Code Information Lot Number / Expiration Date:1001381/2008-08 UPC Codes:C8004 +H699C80040K 
Recalling Firm/
Manufacturer		 Applied Medical Resources Corp
22872 Avenida Empresa # 3
Rancho Santa Margarita CA 92688-2650
For Additional Information Contact Mary Jo Stegwell
949-713-8000
Manufacturer Reason
for Recall		 The Applied GelPort Laparoscopic Hand Access Device, Model C8004. product is being recalled due to an incorrect component. The incorrect Wound Retractor base was packaged with the kit.
FDA Determined
Cause 2		 Process control
Action The recall was initiated on October 14,2005. Applied Medical will contact all customers involved in the recall via overnight FEDEX / UPS. A follow-up communication concerning the recall notification letter will be sent to each of the customers who have not responded with 30 days.Applied is requesting product lot listed in the notification be returned to Applied Medical. All product involved in the recall will be destroyed.
Quantity in Commerce 117 Units
Distribution Nationwide
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = GCJ and Original Applicant = APPLIED MEDICAL RESOURCES CORP.
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