Reported Feb 7, 2024 · Ongoing
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Microvention Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MICROVENTION INC. · 35 Enterprise · Aliso Viejo, CA · 92656
Is this the product you have?
- TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
- Lot codes and dates
- Model/Catalog NumberHP2S0600
- UDI Code(01)00816777026118(11)230710(17)260630(10)0000342047
- Lot Number0000342047
- Amount recalled
- 22 units
Where it was sold
Why it was recalled
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
This product could cause temporary or reversible health problems — stop using it.
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