FDAFDA · Food and drugs·Recall number Z-0868-2024
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Published February 7, 2024 · Recall initiated: December 21, 2023
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
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MICROVENTION INC.
- Distributor
- U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.
- Lot
- Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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