TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
FDA Recall #Z-0868-2024 — Class II — December 21, 2023
Product Description
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Reason for Recall
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Recalling Firm
MICROVENTION INC. — Aliso Viejo, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
22 units
Distribution
U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.
Code Information
Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated