Recall Z-0986-2020 ยท DWJ System, Thermal Regulating
Care Essentials Pty., Ltd.
Cocoon Convective Warming System, Product Code: CWS4000 (110V).
| Date | Jan 7, 2020 |
| 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. |
| Root cause | Other |
| Action | On January 7, 2020 the firm distributed Urgent Medical Device Recall Communication letters by FedEx stating: URGENT- Medical Device Field Correction Dear Valued Customer: Care Essentials (CE) is writing to advise you that, as a precautionary measure, we are issuing a voluntary product repair of CWS4000 and CWS5000 (110V) Cocoon Convective Warming Machines devices due to a report of thermal damage to the power entry module and power cord in a hospital in Canada. The affected devices were distributed in the U.S. from the date of March 3rd, 2015. There are no reported instances of death or serio |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140635 | COCOON CONVECTIVE WARMING SYSTEM Care Essentials Pty, Ltd., Jul 25, 2014 |