Recall Z-2779-2020 ยท LRR First Aid Kit With Drug
HF Acquisition Co. LLC
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.
| Date | Jun 5, 2020 |
| Status | Terminated |
| Reason | A missing component (hand suction pump) in the emergency medical kits. |
| 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 | 2 kits |
| Distribution | US Nationwide distribution including in the states of TN and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.