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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.

FDA Recall Z-2779-2020 · Posted None

Recalling FirmHF Acquisition Co. LLC
Recall StatusTerminated
Product CodeLRR
Date Initiated2020-06-05
Date Terminated2022-02-01
Product Quantity2 kits

Reason for Recall

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

Firm 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.

Root Cause

Process change control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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