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Stat 2 Primary Administration Set and Extension Set Gravity Flow Controller (2017-06-19)
- Starting date:
- June 19, 2017
- Posting date:
- July 11, 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-63890
Affected Products
A. Stat 2 Primary Administration Set Gravity Flow Controller
B. Stat 2 Extension Set Gravity Flow Controller
Reason
CONMED determined that certain devices were assembled with an incorrectly-dimensioned supplier component, which may cause the device to exhibit inaccurate or inconsistent flow rates. If the device is unable to regulate flow, as set and confirmed by the attending medical staff, and the delivery of essential medications or treatment is dependent on the device's function, this may result in possible injury to the patient.
Affected products
A. Stat 2 Primary Administration Set Gravity Flow Controller
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
S2V-20
S2V-20 N
S2V-60
S2V-60 N
Companies
- Manufacturer
-
Conmed Corporation
525 French Road
Utica
13502
New York
UNITED STATES
B. Stat 2 Extension Set Gravity Flow Controller
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
S2-12
S2-12 N
Companies
- Manufacturer
-
Conmed Corporation
525 French Road
Utica
13502
New York
UNITED STATES