STEP-HAR MEDICAL LLC

FDA Regulatory Profile

STEP-HAR MEDICAL LLC appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1543-2021, Class I) was initiated on February 26, 2021.

Summary

Total Recalls
1 (1 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1543-2021Class IAlaris Pump Module, Model 8100, serviced/repaired by Step-Har Medical with an impacted bezel repair February 26, 2021