AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Summary
The FDA issued a Class II for AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 by MICROVENTION INC.. Reason: Peripheral coil system detachable has a potential of unsealed pouch packaging..
Details
Source
Device Recall
External ID
Z-0187-2024
Action Date
2023-11-08
Status
Ongoing
Category
device
Product Description
AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Lot/Code Info: UDI-DI: 00812636021089, Lot: 0000190693, Expiration: 4/30/2027
Quantity Affected: 14
Reason for Recall
Peripheral coil system detachable has a potential of unsealed pouch packaging.
Distribution
US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-24
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 156 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-0187-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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