Lansdale, PA, United States
Vygon U.S.A. recalls
3 recalls recorded since 2018, most recently on 15 April 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 15 April 2021
- Reason
- Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
- Distribution
- US Nationwide distribution in the state of PA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1689-2021
- Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Terminated Class II Medical devices
- Recall started
- 6 December 2018
- Terminated
- 12 May 2020
- Reason
- DualStop Caps defect causing leaks in affected product
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1114-2019, Z-1115-2019
- Vygon DUALSTOP Red Cap used for intravascular lines Product Code: 9888.00 - Product Usage: Cap used for intravascular lines.
- Vyon DUALSTOP White Cap used for intravascular lines Product Code: 9888.002- Product Usage: Cap used for intravascular lines.
Terminated Class II Medical devices
- Recall started
- 28 February 2018
- Terminated
- 19 February 2019
- Reason
- Potential friction holes may affect the sterility of the product.
- Distribution
- Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1637-2018, Z-1640-2018, Z-1636-2018, Z-1635-2018, Z-1638-2018, Z-1639-2018, Z-1634-2018, Z-1633-2018
- PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.
- PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.
- Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.
- Maximum Barrier Tray, Product Code: AMS-9018CP Convenience kit for the insertion of PICCs into the vascular system.
- Maximum Barrier Tray, Product Code: MCITX-1 Convenience kit for the insertion of PICCs into the vascular system.
- PICC Insertion Tray, Product Code: AMS-7192CS-3 Convenience kit for the insertion of PICCs into the vascular system.
- Neonatal PICC Tray, Product Code: AMS-8010CP-1 Convenience kit for the insertion of PICCs into the vascular system.
- PICC Kit, Product Code: AMS-7063-1 Convenience kit for the insertion of PICCs into the vascular system.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.