Recall Z-1689-2021— Vygon U.S.A.
Class II · Ongoing
Class II FDA medical device recall by Vygon U.S.A., initiated 2021-04-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.. Reason: Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection.
- Recalling firm
- Vygon U.S.A.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-04-15
- Firm location
- Lansdale, PA, United States
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.