Home / Recalls / Vygon U.S.A. / Z-1689-2021

Z-1689-2021 Class II Ongoing

Recalled by Vygon U.S.A. — Lansdale, PA

FDA device recall Z-1689-2021 was initiated by Vygon U.S.A. on Apr 15, 2021 and is designated Class II. 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 The recall status is ongoing. Affected quantity: 8,320 units.

Recall details

Product Type: Devices
Report Date: Jun 9, 2021
Initiation Date: Apr 15, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product 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.

Code information

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1689-2021
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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