FDA Recall Terminated

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.

Recall: Z-2779-2020 · Initiated June 5, 2020

Recall

Recall Number
Z-2779-2020
Event Number
85898
Firm
HF Acquisition Co. LLC
FEI Number
3014534
Product Code
LRR
Status
Terminated
Root Cause
Process change control
Initiated
June 5, 2020
Terminated
February 1, 2022
Address
11629 49th Pl W, Mukilteo, WA, 98275-4255

Description

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.

Reason

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

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.

Distribution

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

Quantity

2 kits