Medical device recalls Moderate risk

Cocoon Convective Warming System recalled over fire hazard

Recall date
January 7, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Care Essentials Pty., Ltd. recalls Cocoon Convective Warming System, Product Code: CWS5000 (110V).
Recall number
Z-0987-2020
FDA classification
Class II
Brand / firm
Care Essentials Pty., Ltd.
Sold / distributed
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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cocoon Convective Warming System, Product Code: CWS5000 (110V).

Get recall alerts

Free email alert whenever Care Essentials Pty., Ltd. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Care Essentials Pty., Ltd.