Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2779-2020Class II

STAT KIT Z-1000 emergency medical kit HealthFirst -

HF Acquisition Co. LLC / initiated 2020-06-05 / Terminated

HF Acquisition Co. LLC began a recall of STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physicians with advanced cardiac life support devices and medications... on . FDA classified it as Class II and gives the reason as "A missing component (hand suction pump) in the emergency medical kits". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-2779-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
HF Acquisition Co. LLC
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.
Product code
LRR First Aid Kit With Drug
Reason for recall
A missing component (hand suction pump) in the emergency medical kits.
FDA root cause
Process change control
Action
On June 5, 2020, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification to customers via UPS Priority Overnight, informing them that their emergency medical kits were supplied without one of the intended medical devices inside. The notification informed the customers that the Recalling Firm is supplying the missing item and for them to place it inside their emergency medical kits. For any questions or information contact the Recalling Firm at 1-800-331-1984.
Quantity in commerce
2 kits
Distribution
US Nationwide distribution including in the states of TN and UT.
Product codes and lots
STAT KIT Z-1000 Emergency Medical Kit Part Number: 1003550  AMBU Res-Cue Pump part number: 1004330

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2779-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2779-2020Class IITerminatedVoluntary: Firm initiated