Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Reported: June 9, 2021 Initiated: April 15, 2021 #Z-1689-2021
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
Details
- Recalling Firm
- Vygon U.S.A.
- Units Affected
- 8,320 units
- Distribution
- US Nationwide distribution in the state of PA.
- Location
- Lansdale, PA
Frequently Asked Questions
What product was recalled? ▼
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.. Recalled by Vygon U.S.A.. Units affected: 8,320 units.
Why was this product recalled? ▼
Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 9, 2021. Severity: Moderate. Recall number: Z-1689-2021.
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