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U.S. Department of Health and Human Services

Class 2 Device Recall Vaxcel Low Profile plastic port (nonvalved)

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  Class 2 Device Recall Vaxcel Low Profile plastic port (nonvalved) see related information
Date Initiated by Firm June 08, 2005
Date Posted June 30, 2005
Recall Status1 Terminated 3 on February 15, 2007
Recall Number Z-0946-05
Recall Event ID 32167
510(K)Number K032375  K032600  
Product Classification Port & Catheter, Implanted, Subcutaneous, Intraperitoneal - Product Code LLD
Product Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter, Catalog # 45-338, Material #M001453380. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.
Code Information 791549, 915868, 919482, 922594, 923705, 1000906, 1001279, 1003265, 1022911, 1034615, 922594D, 923705D
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Kathryn Thorp
508-652-4026
Manufacturer Reason
for Recall		 Potential for port housing separation after implantation.
FDA Determined
Cause 2		 Other
Action A recall package issued to direct accounts on 6/8/05. Hospitals are instructed to return product in inventory, notify physicians, evaluate patients and explant devices whenever possible.
Distribution Product shipped to 56 medical facilities throughout the U.S.
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 = LLD and Original Applicant = BOSTON SCIENTIFIC CORP.
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