Recall Z-0986-2020— Care Essentials Pty., Ltd.

Name: FDA recall Z-0986-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-07

Class II · Terminated

Class II FDA medical device recall by Care Essentials Pty., Ltd., initiated 2020-01-07, terminated 2023-03-22. It names one FDA 510(k) clearance: K140635. Product: Cocoon Convective Warming System, Product Code: CWS4000 (110V).. 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..

Recalling firm: Care Essentials Pty., Ltd.
Classification: Class II
Status: Terminated
Initiated: 2020-01-07
Terminated: 2023-03-22
Firm location: North Geelong, N/A, Australia

510(k) clearances named in this recall

1 on FDA's record

K140635 — COCOON CONVECTIVE WARMING SYSTEMCare Essentials Pty, Ltd.·cleared 2014-07-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Cocoon Convective Warming System, Product Code: CWS4000 (110V).

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.