FDA recall Z-0987-2020

Product

Cocoon Convective Warming System, Product Code: CWS5000 (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.

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.

Key facts

Status

Terminated

Initiation date

2020-01-07

Report date

2020-02-12

Termination date

2023-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Geelong, N/A, Australia

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0987-2020