This page has been archived on the Web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.
Pak, Ultrasound Fluidics Management System (2014-11-04)
- Starting date:
- November 4, 2014
- Posting date:
- November 18, 2014
- 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-42101
Recalled Products
Pak, Ultrasound Fluidics Management System
Reason
Alcon received complaints for the Infiniti Ultrasound Paks related to occlusion of the aspiration line. The quality review processes showed an equipment misalignment which may have potentially detached a piece of the aspiration tubing and inserted it into the aspiration line of the Infiniti Ultrasound Paks. This recall is being conducting due to the fact that the possibility exists for a loss of aspiration performance during surgery which may pose a safety risk to patients.
Affected products
Pak, Ultrasound Fluidics Management System
Lot or serial number
- 1623756H
- 1642433H
- 1642478H
- 1647970H
- 1647977H
Model or catalog number
- 8065-7410-80
- 8065-7410-81
- 8065-7410-83
Companies
- Manufacturer
-
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth
76134
Texas
UNITED STATES