TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Summary
The FDA issued a Class II for TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 by MICROVENTION INC.. Reason: Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distr.
Details
Source
Device Recall
External ID
Z-0868-2024
Action Date
2024-02-07
Status
Ongoing
Category
device
Product Description
TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Lot/Code Info: Model/Catalog Number: HP2S0600 UDI Code: (01)00816777026118(11)230710(17)260630(10)0000342047 Lot Number: 0000342047
Quantity Affected: 22 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-21
Company
Aliso Viejo, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 221 device recalls issued in the same week, part of 403 device-related FDA actions this month.
MICROVENTION INC. has 18 FDA actions in our database, including 11 recalls and 7 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MICROVENTION INC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MICROVENTION INC. have FDA actions?
MICROVENTION INC. has 18 FDA actions in our database, including 11 recalls and 7 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0868-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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