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Recall Observatory FDA recall evidence

Device product

STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications to respond to cardiopulmonary medical emergencies until EMS arrives.

Z-2779-2020

June 05, 2020

Class II

Product summary

Firm
HF Acquisition Co. LLC
Event
Event 85898
Status
Terminated
Classification
Class II
Quantity
2 kits
Official record key
device-enforcement:Z-2779-2020

Official wording

Reason: A missing component (hand suction pump) in the emergency medical kits.

Code information: STAT KIT Z-1000 Emergency Medical Kit Part Number: 1003550 AMBU Res-Cue Pump part number: 1004330

Distribution pattern: US Nationwide distribution including in the states of TN and UT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A missing component (hand suction pump) in the emergency medical kits.