Cocoon Convective Warming Machine (2019-11-18)
- Starting date:
- November 18, 2019
- Posting date:
- November 29, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-71752
Last updated: 2019-12-02
Affected Products
Cocoon Convective Warming Machine
Reason
Thermal damage occurred in some CWS4000 devices due to repeated insertion/removal and movement of power cord in the power entry module which lead to improper contact. Fluid ingress may also have contributed to the issue. Devices will be fitted with P-clips to immobilize power cord, and IFU updated.
Affected products
Cocoon Convective Warming Machine
Lot or serial number
All lots.
Model or catalog number
CWS 4000
CWS 5000
Companies
- Manufacturer
-
Care Essentials PTY LTD.
25-27 Slevin Street, North Geelong
Victoria
AUSTRALIA