Tenacore LLC

FDA Regulatory Profile

Summary

Total Recalls
2 (2 Class I)
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1331-2021Class IAlaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair February 25, 2021
Z-1332-2021Class IAlaris Infusion Pump 8100 Bezel (plastic piece only), Part: TIPA-8100-4410February 25, 2021