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U.S. Department of Health and Human Services

Class 2 Device Recall VYGON LIFECATH S PICC

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  Class 2 Device Recall VYGON LIFECATH S PICC see related information
Date Initiated by Firm April 26, 2011
Date Posted June 29, 2011
Recall Status1 Terminated 3 on June 01, 2012
Recall Number Z-2700-2011
Recall Event ID 58810
510(K)Number K062425  
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
Product LIFECATH S PICC with Microflash Introducer
Catheter, Percutaneous, Intravascular
Product Code 2296.214


Product Usage: Intravascular catheter
Code Information Lot #s: 10I02, S0535, S0624, S0625, S0626, S1025
Recalling Firm/
Manufacturer		 Vygon Corporation
103 A Park Drive
Montgomeryville PA 18936-9613
For Additional Information Contact Cindy Varughese
800-473-5414 Ext. 248
Manufacturer Reason
for Recall		 Peripherally inserted central catheter has the potential to leak or break at the hub while in use, which could lead to a loss of blood or catheter migration.
FDA Determined
Cause 2		 Other
Action Vygon Corporation sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 26, 2011. The letter identified the affected products, problem, and actions to be taken. The customers were instructed to check inventory and quarantine all affected products; immediately cease use and distribution of all affected products; return any affected products using the instruction from Customer Service involving product pickup (contact Customer Service at 1-800-473-5414 for a Return Merchandise Authorization number); and immediately complete and return the attached form via fax to 215-390-2019. Distributors were provided with instructions on how to handle products that were further distributed. If you have any questions, please contact your local sales representative or Vygon's Customer Service Department at 1-800-473-5414, or by e-,ail at customerservice@yygonus.com.
Quantity in Commerce 600 individual units
Distribution Nationwide Distribution--USA including states of: AZ, CA, FL, MO, NE, NJ, NY, PA, TX, UT, VA, and WA.
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 = LJS and Original Applicant = VYGON CORP.
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