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Recall Observatory FDA recall evidence

Device product

Aspiration Syringe Kit, REF: MVSK60

Z-0202-2022

October 20, 2021

Class II

Product summary

Firm
MICROVENTION INC.
Event
Event 88892
Status
Terminated
Classification
Class II
Quantity
33
Official record key
device-enforcement:Z-0202-2022

Official wording

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

Code information: Lot: H2146461; UDI: (01)00816777025906(11)210727(17)240430(10)H2146461

Distribution pattern: US Nationwide distribution in the states of AL, NY, NV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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