Health product recall

Temperature Probes

Last updated

Summary

Product
Temperature Probes
Issue
Medical devices - Revised instructions for use
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Disposable Temperature Probes

All lots.

21076A, 21075A

Skin Temperature Probe

All lots.

21078A

Issue

The esophageal/rectal/skin temperature probe's instructions for use, (IFU), contain inadequate instructions related to the cleaning and disinfection process for the reusable probes. The IFU instructs the user to clean the product with disinfecting agents but does not specifically instruct the user to first clean with an enzymatic solution (detergent) before disinfecting or sterilizing. Cleaning the probes with a detergent allows for the physical removal of soil and other contaminants.

Recall start date: Feb 7, 2022

Additional information

Details
Original published date: 2022-02-22
Alert / recall type
Health product recall
Category
Health product - Medical device - General hospital and personal use
Companies

Philips Medical Systems

3000 Minuteman Road, Andover, Massachusetts

United States, 01810

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type III
Identification number
RA-63940