FDA Medical Device Recalls (openFDA)
Vygon U.S.A.: Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
- Recall number
- Z-1114-2019
- Recalling firm
- Vygon U.S.A.
- Product
- Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
- Status
- Terminated
- Initiated
- 2018-12-06
- Posted
- not on file
- Terminated
- 2020-05-12
- 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.
- Lot, serial or model codes
- Lot codes: 310518FD 050618FD 140318FD 160617FD 200917FD 061117FD 090118FD 200218FD 290318FD 110418FD
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2245270
- Firm city
- Lansdale
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28