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CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK (2016-05-04)
- Starting date:
- May 4, 2016
- Posting date:
- May 24, 2016
- 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-58506
Affected products
- CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK, BASIC
- CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK, INFUSION SLEEVES
- CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK, W/INTREPID ULTRA SLEEVES
Reason
Alcon Canada is conducting this voluntary medical device removal for specific lots of CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration leur which may result in a reduction of vacuum within the aspiration line.
Affected products
A. CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK, BASIC
Lot or serial number
1794104H
1794108H
Model or catalog number
8065752180
Companies
- Manufacturer
-
Alcon Laboratories Inc.
6201 South Freeway
Fort Worth
Texas
UNITED STATES
B. CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK, INFUSION SLEEVES
Lot or serial number
1801714H
1802311H
Model or catalog number
8065752917
8065752918
Companies
- Manufacturer
-
Alcon Laboratories Inc.
6201 South Freeway
Fort Worth
Texas
UNITED STATES
C. CENTURION VISION SYSTEM - ACTIVE IRRIGATION FMS PACK, W/INTREPID ULTRA SLEEVES
Lot or serial number
1794153H
1794154H
1794155H
1794159H
1794161H
1794163H
1794164H
1794168H
1802317H
1804670H
1804691H
1804696H
1804697H
1804698H
1804849H
Model or catalog number
8065752200
8065752201
Companies
- Manufacturer
-
Alcon Laboratories Inc.
6201 South Freeway
Fort Worth
Texas
UNITED STATES