This page has been archived on the Web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.
FMS Sterile Intermediary Tubing (2013-08-30)
- Starting date:
- August 30, 2013
- Posting date:
- September 27, 2013
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type I
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-35919
Recalled products
A. FMS Sterile Intermediary Tubing
Reason
Internal testing has found that the check valve (Pillow valve) included in the FMS (Fluid Management System) intermediary tubing set may not be performing as intended. If the controls described in the operator's manual are not followed, this defect may result in backflow of irrigation fluid into the one-day set which may potentially lead to patient cross-contamination.
Affected products
FMS Sterile Intermediary Tubing
Lot or serial number
- D316810
Model or catalog number
- 281142
Companies
- Manufacturer
-
Depuy Mitek
325 Paramount Drive
Raynham
02767
Massachusetts
UNITED STATES