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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 December 06, 2018
Create Date April 09, 2019
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-1114-2019
Recall Event ID 81866
Product Classification Set, administration, intravascular - Product Code FPA
Product Vygon DUALSTOP Red Cap used for intravascular lines
Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
Code Information Lot codes:  310518FD 050618FD 140318FD 160617FD 200917FD 061117FD 090118FD 200218FD 290318FD 110418FD
Recalling Firm/
Vygon U.S.A.
2750 Morris Rd Ste A200
Lansdale PA 19446-6083
For Additional Information Contact SAME
Manufacturer Reason
for Recall
DualStop Caps defect causing leaks in affected product
FDA Determined
Cause 2
Equipment maintenance
Action Vygon issued recall letter on 12/6/18 via email or fax stating the defect, health risk and action to be taken. Distributors were provided with instructions on how to handle product that was further distributed by them. Contact your local sales representative or Vygons Customer Service Department at 1-800-473-5414, or by e-mail at customerservice@vygonus.com
Quantity in Commerce 339,800
Distribution US Nationwide distribution.
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.