Z-0868-2024 Class II Ongoing
FDA device recall Z-0868-2024 was initiated by MICROVENTION INC. on December 21, 2023 and is designated Class II. Reason for recall: Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed. The recall status is ongoing. Affected quantity: 22 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2024
- Initiation Date
- December 21, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 units
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.
Distribution Pattern
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