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Health product recall

Vital Signs Adult Volume Ventilator Circuits and Heated Wire Respiratory Circuits (2013-12-25)

Starting date:
December 25, 2013
Posting date:
February 10, 2014
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-37835

Recalled Products

A. Adult Volume Ventilator Circuits
B. Heated Wire Respiratory Circuits

Reason

Certain vital signs breathing circuits may be provided with 15 mm blue port caps as a loose component and/or 22 mm blue port caps attached to certain circuit ports. They are not intended to be part of the final circuit assembly. If the circuit assembly is used with the cap in place it will cause occlusion of gas flow. Occlusion of gas flow can result in varying degrees of hypoxia which may be severe.

Affected products

A. Adult Volume Ventilator Circuits

Lot or serial number

All lots

Model or catalog number

155200EU
1552016
1553402
156205
156310
1574710
1574723

Companies
Manufacturer
Vital Signs Inc.
a GE Healthcare company
11039 East Lansing Circle
Englewood
80112
Colorado
UNITED STATES

B. Heated Wire Respiratory Circuits

Lot or serial number

All lots

Model or catalog number

155518

Companies
Manufacturer
Vital Signs Inc.
a GE Healthcare company
11039 East Lansing Circle
Englewood
80112
Colorado
UNITED STATES