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MICROVENTION INC. recalls TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Recalled February 7, 2024 · FDA recall Z-0868-2024 · MICROVENTION
Hazard
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed. · FDA Class II
Units
22 units
Sold at
U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.
Description
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Product
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Manufacturer(s)
MICROVENTION INC.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →