Summary
The FDA issued a Class II for Aspiration Syringe Kit, REF: MVSK60 by MICROVENTION INC.. Reason: Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers..
Details
Source
Device Recall
External ID
Z-0202-2022
Action Date
2021-11-10
Status
Terminated
Category
device
Product Description
Aspiration Syringe Kit, REF: MVSK60
Lot/Code Info: Lot: H2146461; UDI: (01)00816777025906(11)210727(17)240430(10)H2146461
Quantity Affected: 33
Reason for Recall
Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
Distribution
US Nationwide distribution in the states of AL, NY, NV.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-20
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 120 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-0202-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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