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U.S. Department of Health and Human Services

Class 2 Device Recall 20Ga x .75 LifeGuard Huber Needle with Ysite

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  Class 2 Device Recall 20Ga x .75 LifeGuard Huber Needle with Ysite see related information
Date Initiated by Firm July 24, 2017
Create Date February 21, 2018
Recall Status1 Terminated 3 on November 07, 2019
Recall Number Z-0679-2018
Recall Event ID 78951
510(K)Number K013871  
Product Classification Set, administration, intravascular - Product Code FPA
Product 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
Code Information Lot Number: 1706017D
Recalling Firm/
Manufacturer		 Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
87 Venture Dr
Dover NH 03820-5914
Manufacturer Reason
for Recall		 Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
FDA Determined
Cause 2		 Under Investigation by firm
Action Vygon sent recall letters dated July 24, 2017, to customers via email and fax with read receipts and delivery confirmations. The recall letter informed customers of the reason for recall, product description, code and lot number, and instructions to customers, with a Recall Acknowledgement and Inventory Return Form provided/accompanying the recall letter.
Quantity in Commerce 396 units
Distribution 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 = FPA and Original Applicant = HORIZON MEDICAL PRODUCTS, INC.
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