LifeHealth, LLC

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0160-2016Class IIBG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, dispSeptember 16, 2015
Z-0159-2016Class IICC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disSeptember 16, 2015
Z-1919-2015Class IILifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitroApril 29, 2015