FDA-Device2021-11-10Class II

Aspiration Syringe Kit, REF: MVSK60

Hazard

Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.

Sold states
US Nationwide distribution in the states of AL, NY, NV.
Affected count
33
Manufactured in
35 Enterprise, N/A, Aliso Viejo, CA, United States
Products
Aspiration Syringe Kit, REF: MVSK60

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0202-2022

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