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U.S. Department of Health and Human Services

Class 2 Device Recall Lap Banding Kit

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  Class 2 Device Recall Lap Banding Kit see related information
Date Initiated by Firm June 25, 2008
Date Posted October 07, 2008
Recall Status1 Terminated 3 on March 26, 2012
Recall Number Z-0028-2009
Recall Event ID 49445
510(K)Number K012884  
Product Classification laparoscopic trocar - Product Code GCJ
Product Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Code Information Product/Kit Batch Numbers: 1059718, 1060488, 1061516, 1062296, 1063810
Recalling Firm/
Manufacturer		 Applied Medical Resources Corp
22872 Avenida Empresa
Rancho Santa Margarita CA 92688
For Additional Information Contact
949-713-8000
Manufacturer Reason
for Recall		 Potential inability to insufflate through the stopcock. Under certain circumstances, a flexible elastomeric component inside the 15mm trocar can stretch into a configuration that blocks the flow of insufflation gas (C02).
FDA Determined
Cause 2		 Process control
Action Customers were notified via FedEx or UPS on June 25,2008 with an overnight letter. The letter advises that Applied Medical is conducting a voluntary recall of the 15mm Separator Access Systems, Models C0604, C0605, C0606 and C0607 due to the potential inability to insufflate through the stopcock. Per the letter, the firm is asking that all 15mm product listed in the letter be returned. A response form is provided.
Quantity in Commerce 14,113 total
Distribution Nationwide and Canada distribution.
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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