HF Acquisition Co., LLC
Medical device manufacturer in Mukilteo, WA.
0510(k) clearances
0PMA approvals
8recalls
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2332-2026 Class II | Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ…Due to incorrect incubation process being performed on product. | 04/13/2026Open, Classified |
| Z-2331-2026 Class II | Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ…Due to incorrect incubation process being performed on product. | 04/13/2026Open, Classified |
| Z-1141-2025 Class II | Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600.…Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a… | 12/11/2024Open, Classified |
| Z-2779-2020 Class II | STAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to…A missing component (hand suction pump) in the emergency medical kits. | 06/05/2020Terminated |
| Z-2791-2020 Class II | STAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to…Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. | 06/04/2020Terminated |
| Z-2790-2020 Class II | STAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to…Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. | 06/04/2020Terminated |
| Z-2789-2020 Class II | STAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to…Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. | 06/04/2020Terminated |
| Z-2788-2020 Class II | HealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF…Instead of 2 doses, packaged 1 dose of nasal spray in an emergency kits. | 06/04/2020Terminated |