This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
D-Fend Water Traps (2015-04-16)
- Starting date:
- April 16, 2015
- Posting date:
- May 6, 2015
- 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-53257
Recalled Products
A. D-Fend Water Traps
Reason
Occlusion of specific lots of D-fend/D-fend+ Water Traps could occur immediately after replacement. This water trap occlusion could cause a loss of respiratory airway gas monitoring. When this issue is detected the connected monitoring device will issue an audio alarm and display "low gas sample flow", "replace water trap" or "sampling line blocked" warning messages. Unattended or prolonged warnings could lead to an adverse clinical situation if the CO2 value would rapidly change in certain clinical conditions.
Affected products
A. D-Fend Water Traps
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
876446
881319
Companies
- Manufacturer
-
GE Healthcare Finland OY
Kuortaneenkatu 2,
Helsinki
00510
FINLAND