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Health product recall

The Ivent 201 Disposable Breathing Patient Circuit (2014-01-13)

Starting date:
January 13, 2014
Posting date:
February 11, 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-37881

Recalled products

  1. The Ivent 201 Disposable Breathing Patient Circuit

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.

Affected products

A. The Ivent 201 Disposable Breathing Patient Circuit

Lot or serial number

Not applicable

Model or catalog number
  • M1171508
Companies
Manufacturer
GE Medical Systems Israel Ltd.
Hasharon Industrial Park, Ornat Building
Kadima
0060920
ISRAEL