FDAFDA · Food and drugs·Recall number Z-0504-2023
HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray
Published December 21, 2022 · Recall initiated: November 2, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Stradis Medical, LLC dba Stradis Healthcare
- Distributor
- US nationwide distribution, and Canada.
- Lot
- UDI/DI (case) H65857014621, UDI/DI (kit)M75257014620, Serial/Lot Numbers: 22230491082
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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