FDAFDA · Food and drugs·Recall number Z-0596-2024
Regard Dressing change kit, Item Number 800026006
Published January 10, 2024 · Recall initiated: November 20, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- ROi CPS LLC
- Distributor
- US Nationwide distribution in the state of Louisiana.
- Lot
- UDI/DI 10194717107873, Lot Numbers: 98283, 97591, 97405, 97081, 96961, 95508, 94769, 94435, 94270
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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