HF Acquisition Co LLC

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
0
Inspections
9
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1141-2025Class IIBiological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12December 11, 2024
D-0870-2023Class IIIGLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisition Co. LLC, Mukilteo, June 6, 2023
D-1392-2020Class IIIFamotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, For Intravenous Use OnlyJune 17, 2020
Z-2779-2020Class IISTAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare physiciansJune 5, 2020
Z-2790-2020Class IISTAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to include Narcan June 4, 2020
Z-2789-2020Class IISTAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to include NarJune 4, 2020
Z-2788-2020Class IIHealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF Acquisition Co. LLC,June 4, 2020
Z-2791-2020Class IISTAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to include NarcJune 4, 2020