FDA-Device2024-02-07Class II
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
MICROVENTION INC.
Hazard
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Sold states
U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.
Affected count
22 units
Manufactured in
35 Enterprise, Aliso Viejo, CA, United States
Products
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0868-2024Don't want to check this manually?
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