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

FDA Device Recall #Z-1689-2021 — Class II — April 15, 2021

Recall Summary

Recall Number Z-1689-2021
Classification Class II — Moderate risk
Date Initiated April 15, 2021
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Vygon U.S.A.
Location Lansdale, PA
Product Type Devices
Quantity 8,320 units

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

Distribution Pattern

US Nationwide distribution in the state of PA.

Lot / Code Information

Lot Number: 203373129 Exp. Date: June 30, 2022

Other Recalls from Vygon U.S.A.

Recall # Classification Product Date
Z-1114-2019 Class II Vygon DUALSTOP Red Cap used for intravascular l... Dec 6, 2018
Z-1115-2019 Class II Vyon DUALSTOP White Cap used for intravascular ... Dec 6, 2018
Z-1637-2018 Class II PICC Tray, Product Code: AMS-9093CP Conveni... Feb 28, 2018
Z-1640-2018 Class II PICC Insertion Tray, Product Code: AMS-7192CS-4... Feb 28, 2018
Z-1636-2018 Class II Maximum Barrier Insertion Tray, Product Code: A... Feb 28, 2018

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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