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Pump, Medfusion 3500 and 4000 (2017-06-27)
- Starting date:
- June 27, 2017
- Posting date:
- July 18, 2017
- 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-64014
Reason
Smiths Medical became aware that the thread lock material used on a fastening screw can be ineffective. As a result, the Medfusion pump syringe barrel clamp mechanism may loosen and decrease the pump's ability to accurately detect the outside diameter measurement of the syringe barrel, causing an "invalid syringe size" alarm to occur.
Affected products
A. Pump, Medfusion, Model 3500
Lot or serial number
More than 100 numbers, contact manufacturer
Model or catalog number
3500-500
Companies
- Manufacturer
-
Smiths Medical ASD, Inc.
1265 Grey Fox Road
St. Paul
55112
Minnesota
UNITED STATES
B. Pump, Medfusion 4000
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
4000-0101-51
4000-0105-51
Companies
- Manufacturer
-
Smiths Medical ASD, Inc.
1265 Grey Fox Road
St. Paul
55112
Minnesota
UNITED STATES