Vygon Dressing Change w/ Maxiswab - Product Usage recall: Sterility Concern
Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
Why was Vygon Dressing Change w/ Maxiswab - Product Usage recalled?
Compromised sterile barriers due to the Tyvek Lid not properly adhering to the Tray and has the the potential to cause an infection
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: 203373129 Exp. Date: June 30, 2022
- Product
- Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
- Recalling firm
- Vygon U.S.A.
- Quantity
- 8,320 units
- Distribution
- US Nationwide distribution in the state of PA.
- Recall date
- June 9, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)