CAREstream Medical LLC

FDA Regulatory Profile

CAREstream Medical LLC appears in FDA public data with 1 recall, 0 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2887-2018, Class II) was initiated on May 15, 2018.

Summary

Total Recalls
1
510(k) Clearances
0
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2887-2018Class IICAREstream ProNox Nitrous Oxide Delivery System labeled as the following: a. CMI-0100 PNX, Pro-NMay 15, 2018