Date Initiated by Firm | June 05, 2020 |
Create Date | August 10, 2020 |
Recall Status1 |
Terminated 3 on February 01, 2022 |
Recall Number | Z-2779-2020 |
Recall Event ID |
85898 |
Product Classification |
First Aid Kit with drug - Product Code LRR
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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. |
Code Information |
STAT KIT Z-1000 Emergency Medical Kit Part Number: 1003550 AMBU Res-Cue Pump part number: 1004330 |
Recalling Firm/ Manufacturer |
HF Acquisition Co. LLC 11629 49th Pl W Mukilteo WA 98275-4255
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Manufacturer Reason for Recall | A missing component (hand suction pump) in the emergency medical kits. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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