FDA recall Z-1689-2021

Vygon U.S.A. · Class II · device

Product

Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.

Reason for recall

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.

Key facts

Status
Ongoing
Initiation date
2021-04-15
Report date
2021-06-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lansdale, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1689-2021