FDA recall Z-0868-2024

Product

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.

Distribution

U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.

Key facts

Status

Ongoing

Initiation date

2023-12-21

Report date

2024-02-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Aliso Viejo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0868-2024