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Recall Observatory FDA recall evidence

Device product

TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600

Z-0868-2024

December 21, 2023

Class II

Product summary

Firm
MICROVENTION INC.
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

    reason.no_named_rule · v1.0.0

    Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.