Recall Z-1114-2019 ยท FPA Set, Administration, Intravascular
Vygon U.S.A.
Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
| Date | Dec 6, 2018 |
| Status | Terminated |
| Reason | DualStop Caps defect causing leaks in affected product |
| Root cause | 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 | 339,800 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.