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Ambulatory Infusion Pumps (2015-12-24)
- Starting date:
- December 24, 2015
- Posting date:
- January 25, 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-56784
Affected Products
- Curlin CMS 6000 Ambulatory Volumetric Infusion Pump
- Curlin CMS 4000 Ambulatory Volumetric Infusion Pump
- PAINSMART IOD (AMBULATORY INFUSION PUMP)
Reason
The master pumps used to calibrate manufactured and serviced pumps have a calibration shift of up to 6.8% (+3%). When an affected master pump is used to calibrate production and serviced pumps, this pump is used to calibrate production and serviced pumps, this calibration shift could lead to over delivery of fluid beyond the label claim of +5%.
Affected products
A. Curlin CMS 6000 Ambulatory Volumetric Infusion Pump
Lot or serial number
N/A
Model or catalog number
- 3601100
- 3601400
- 360-2026
Companies
- Manufacturer
-
Zevex Inc. Also Trading as Moog Medical Devices Group
4314 Zevex Park Lane
Salt Lake City
Utah
UNITED STATES
B. Curlin CMS 4000 Ambulatory Volumetric Infusion Pump
Lot or serial number
N/A
Model or catalog number
- 3501000
- 350-1100
- 350-1200
- CURLIN CUSTOM 4000
Companies
- Manufacturer
-
Zevex Inc. Also Trading as Moog Medical Devices Group
4314 Zevex Park Lane
Salt Lake City
Utah
UNITED STATES
C. PAINSMART IOD (AMBULATORY INFUSION PUMP)
Lot or serial number
N/A
Companies
- Manufacturer
-
Zevex Inc. Also Trading as Moog Medical Devices Group
4314 Zevex Park Lane
Salt Lake City
Utah
UNITED STATES