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U.S. Department of Health and Human Services

Class 2 Device Recall STAT KIT Z1000 Emergency Medical Kit

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  Class 2 Device Recall STAT KIT Z1000 Emergency Medical Kit see related information
Date Initiated by Firm June 05, 2020
Create Date August 10, 2020
Recall Status1 Open3, Classified
Recall Number Z-2779-2020
Recall Event ID 85898
Product Classification First Aid Kit with drug - Product Code LRR
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
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

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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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