Health product recall

COMPANION 1000 PORTABLE (2020-10-16)

Starting date:
October 16, 2020
Posting date:
October 30, 2020
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-74217

Last updated:
2020-10-30

Affected Products

COMPANION 1000 PORTABLE

Reason

There is a risk of potential injury to the patient when using the device on 6 LPM after an extended period of time. The design issue identified in the affected product was modified on January 17, 1989. Product manufactured after this date would not have the identified design issue.

Affected products

COMPANION 1000 PORTABLE

Lot or serial number

85010101 to 89011701.
Serial numbers 4-1-01-1 to 5-1-01-XX.

Model or catalog number

B-775099-00

Companies
Manufacturer

CAIRE INC.

2200 Airport Industrial Dr., Suite 500

Ball Ground

30107

Georgia

UNITED STATES