Vygon Dressing Change Kit Recalled for Sterile Barrier Failure Risk
Vygon U.S.A. is recalling 8,320 units of its Dressing Change w/ Maxiswab kit due to improper adhesion of the sterile Tyvek lid to the tray, which could compromise the sterile barrier and potentially cause infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a sterile medical device with a potential sterile barrier defect that could lead to infection. No illnesses or injuries have been reported. Under the severity rubric, this qualifies as a high-severity risk-of-harm product where injury has not yet been reported.
Plain-English summary
Vygon U.S.A. is recalling the Vygon Dressing Change w/ Maxiswab (Product Code: AMS-8465CS), a custom dressing change kit. A total of 8,320 units have been distributed in Pennsylvania. The product is being recalled because the Tyvek lid may not properly adhere to the tray, which can compromise the sterile barrier and potentially cause infection.
The affected lot is Lot Number 203373129, with an expiration date of June 30, 2022.
Those with this product should contact Vygon U.S.A. for recall information and instructions.
The recalled product
- Product
- Vygon Dressing Change w/ Maxiswab - Product Usage: Custom Dressing Change kit, Product Code: AMS-8465CS.
- Manufacturer
- Vygon U.S.A.
- Affected units
- 8,320
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot Number: 203373129 Exp. Date: June 30
- 2022
Distribution
Related recalls
Same manufacturer · Vygon U.S.A.
See all →- HighVygon DUALSTOP White Caps Recalled for Defect Causing Leaks
FDA (Devices) · 2019-04-17
- HighVygon DUALSTOP Red Caps Recalled for Defects Causing Leaks
FDA (Devices) · 2019-04-17
- HighVygon Recalls PICC Insertion Trays Due to Potential Sterility Compromise
FDA (Devices) · 2018-05-16
- HighVygon Recalls PICC Trays Due to Potential Sterility Compromise
FDA (Devices) · 2018-05-16
- HighVygon U.S.A. Recalls Maximum Barrier Tray Due to Sterility Risk
FDA (Devices) · 2018-05-16
Same hazard · sterile barrier failure
See all →- HighDaig Livewire Steerable Electrophysiology Catheter Incomplete Seals Recall
FDA (Devices) · 2026-05-20
- ModerateB Braun Interventional Coaxial Dilator Micro-Introducer Kits Recall
FDA (Devices) · 2025-05-14
- HighVial Decanter Medical Device Recalled for Compromised Sterile Packaging
FDA (Devices) · 2024-08-28
- HighMedtronic Clearview Blower Mister Model 22120 recalled for potential unsealed sterile packing
FDA (Devices) · 2024-05-22
- HighExactech Equinoxe Reverse Shoulder Humeral Liner Recall Due to Nonconforming Packaging
FDA (Devices) · 2024-04-10