North Geelong, N/A, Australia
Care Essentials Pty., Ltd. recalls
1 recall recorded since 2018, most recently on 7 January 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 7 January 2020
- Terminated
- 22 March 2023
- Reason
- Potential for thermal damage near the power cord connector and Power Entry Module (PEM) due to improper connection of the power cord connector and PEM pins on the Cocoon Convective Warming System.
- Distribution
- US Nationwide in the states of AZ CA FL GA KS LA MA MD MI MN NC NM NY OH PA QC SC TX VA WV and the Foreign distribution to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0987-2020, Z-0986-2020
- Cocoon Convective Warming System, Product Code: CWS5000 (110V).
- Cocoon Convective Warming System, Product Code: CWS4000 (110V).
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.