Date Initiated by Firm | December 06, 2018 |
Create Date | April 09, 2019 |
Recall Status1 |
Terminated 3 on May 12, 2020 |
Recall Number | Z-1115-2019 |
Recall Event ID |
81866 |
Product Classification |
Set, administration, intravascular - Product Code FPA
|
Product | Vyon DUALSTOP White Cap used for intravascular lines
Product Code: 9888.002- Product Usage: Cap used for intravascular lines. |
Code Information |
Lot codes: 090718FD 250118FD 081117FD 130218FD 050418FD 020518FD |
Recalling Firm/ Manufacturer |
Vygon U.S.A. 2750 Morris Rd Ste A200 Lansdale PA 19446-6083
|
For Additional Information Contact | SAME 610-539-9300 |
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 | 107700 |
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.
|