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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 PICCsee related information
Date Initiated by FirmApril 26, 2011
Date PostedJune 29, 2011
Recall Status1 Terminated 3 on June 01, 2012
Recall NumberZ-2700-2011
Recall Event ID 58810
510(K)NumberK062425 
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
ProductLIFECATH 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 ContactCindy 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
ActionVygon 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 Commerce600 individual units
DistributionNationwide Distribution--USA including states of: AZ, CA, FL, MO, NE, NJ, NY, PA, TX, UT, VA, and WA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LJS
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