Eight Medical International BV

FDA Regulatory Profile

Eight Medical International BV 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-2005-2021, Class I) was initiated on June 4, 2021.

Summary

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

Recent Recalls

NumberClassProductDate
Z-2005-2021Class IRecirculator 8.0s Disposable Lavage Kit (product code number 8100) , GTIN: 08719992086016. HyperthJune 4, 2021