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U.S. Department of Health and Human Services

Class 2 Device Recall Vygon

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  Class 2 Device Recall Vygon see related information
Date Initiated by Firm January 15, 2015
Date Posted April 21, 2015
Recall Status1 Terminated 3 on February 25, 2016
Recall Number Z-1477-2015
Recall Event ID 70369
510(K)Number K021395  K070705  K963981  
Product Classification Set, administration, intravascular - Product Code FPA
Product 4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV
Accessory device used to administer medical fluids

Code Information 1303121 1305004 1304149 1305011 1306100 1303122 1304003 1305007 1305006 1305012 1306101
Recalling Firm/
Churchill Medical Systems, Inc.
87 Venture Drive
Dover NH 03820-5914
For Additional Information Contact
Manufacturer Reason
for Recall
Potential for leaking caused by insufficient bond between needleless device and female luer.
FDA Determined
Cause 2
Process design
Action Vygon sent an Urgent Medical Device Recall letter dated January 15, 2015, to all affected customers via email or courier service. The letter instructs consignees to check stock for products included in the scope of the recall, count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form" and fax or email the form to Vygon. Vygon customer service will then contact the customer to issue a Return Merchandise Authorization Number so the inventory can be replaced at no cost. Distributors were provided with instructions on how to handle product that was further distributed by them. If after 30-days, product is not returned from each consignee, Vygon will follow-up with the consignee to obtain a status of the product return. Customers with questions were instructed to contact Vygon Customer Service at 1-800-473-5414, or by e-mail at customerservice@vygonus.com.
Quantity in Commerce 2650
Distribution Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
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 = FPA and Original Applicant = CHURCHILL MEDICAL SYSTEMS, INC.
510(K)s with Product Code = FPA and Original Applicant = VYGON CORP.