Class II — Care Essentials Pty., Ltd.
| Recalling firm | CARE ESSENTIALS PTY LTD |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Cocoon Convective Warming System, Product Code: CWS4000 (110V). |
| Quantity | 689 |
| 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 | 2020-01-07 |
| Classified | 2020-02-04 |
| Terminated | 2023-03-22 |
| Recall number | Z-0986-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Care Essentials Pty., Ltd. (Z-0986-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84541/
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