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U.S. Department of Health and Human Services

Class 2 Device Recall AutoSuture

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  Class 2 Device Recall AutoSuture see related information
Date Initiated by Firm October 19, 2006
Date Posted February 08, 2007
Recall Status1 Terminated 3 on October 31, 2008
Recall Number Z-0414-2007
Recall Event ID 37162
510(K)Number K043594  
Product Classification Endoscopic Trocar - Product Code NLM
Product AutoSuture Bladed Trocar, equipped with safety shield. Model number 179094. Available with smooth or threaded sleeve in sizes 5-15mm inner diameter and 70-100mm length.
Code Information 94724 95261 104057 94853 95272 104217 94893 100062 104335 94894 102389 104337 94897 102394 104343 94953 102681 104584 94957 102851 105517 94962 103100  94964 103103  95024 103200  95026 103288  95029 103293  95069 103297  95135 103566  95259 103570
Recalling Firm/
Manufacturer		 Ascent Healthcare Solutions, Inc.
5307 Great Oak Dr
Lakeland FL 33815
Manufacturer Reason
for Recall		 The tip of the trocars may separate before and while in use. In some instances the trocars have been found with exposed blades upon opening the packaging.
FDA Determined
Cause 2		 Process design
Action The recall was initiated on 10/19/2006 by direct distribution of the recall notice to direct accounts by the firm's sales force. The firm also posted the notification on their web site. All customers were instructed to examine their inventories for the product and to remove and quarantine all affected product. Instructions on returning the product to the firm were also included along with a response form.
Quantity in Commerce 1566
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 = NLM and Original Applicant = VANGUARD MEDICAL CONCEPTS, INC.
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