Care Essentials Pty., Ltd.

FDA Regulatory Profile

Care Essentials Pty., Ltd. appears in FDA public data with 2 recalls, 4 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0986-2020, Class II) was initiated on January 7, 2020. Its most recent 510(k) clearance was granted on February 21, 2024.

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0986-2020Class IICocoon Convective Warming System, Product Code: CWS4000 (110V).January 7, 2020
Z-0987-2020Class IICocoon Convective Warming System, Product Code: CWS5000 (110V).January 7, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K232502Cocoon Convective Warming System, Model CWS7000February 21, 2024
K213907CareGUARD Sterilization WrapMarch 14, 2022
K181671Cocoon Convective Warming SystemMay 2, 2019
K140635COCOON CONVECTIVE WARMING SYSTEMJuly 25, 2014