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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 Vygonsee related information
Date Initiated by FirmJanuary 15, 2015
Date PostedApril 21, 2015
Recall Status1 Terminated 3 on February 25, 2016
Recall NumberZ-1471-2015
Recall Event ID 70369
510(K)NumberK021395 K070705 K963981 
Product Classification Set, administration, intravascular - Product Code FPA
Product4" Microbore T-Port Set, Product Code: BN-448 Accessory device used to administer medical fluids
Code Information 1303181 1303100 1304183
Recalling Firm/
Manufacturer
Churchill Medical Systems, Inc.
87 Venture Drive
Dover NH 03820-5914
For Additional Information Contact
800-473-5414
Manufacturer Reason
for Recall
Potential for leaking caused by insufficient bond between needleless device and female luer.
FDA Determined
Cause 2
Process design
ActionVygon 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 Commerce450
DistributionNationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.
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 = FPA
510(K)s with Product Code = FPA
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