FDAFDA · Food and drugs·Recall number Z-2685-2024
Regard Kit containing the Microtek decanter
Published August 28, 2024 · Recall initiated: June 17, 2024
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
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- ROi CPS LLC
- Distributor
- US Nationwide distribution in the state of MO.
- Lot
- Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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