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Recall Observatory FDA recall evidence

Device product

MINISCAV (tm) Vacuum Pump

Z-2619-2023

August 23, 2023

Class II

Product summary

Firm
R A Medical Services
Event
Event 92929
Status
Ongoing
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-2619-2023

Official wording

Reason: Inadequate documentation of acceptance activity

Code information: UDI/DI: (01) 10862552000405. Serial numbers: N/AB/10514 through N/AB/10523

Distribution pattern: Distribution to Ohio

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Inadequate documentation of acceptance activity