Device product
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Z-0868-2024
Product summary
- Event
- Event 93692
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 22 units
- Official record key
device-enforcement:Z-0868-2024
Official wording
Reason: Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Code information: Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047
Distribution pattern: U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.
Derived failure modes
-
Unknown
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.