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Alaris Pump Module Model 8100 (2017-06-12)
- Starting date:
- June 12, 2017
- Posting date:
- September 26, 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-64562
Affected products
Alaris Pump Module Model 8100
Reason
The separation of one or more posts that connect the mechanism frame to the bezel assembly may prevent the device from delivering an accurate amount of fluid flow through the pumping cycle resulting in an over or under infusion condition. In addition, it may prevent the pump from alarming for an upstream or downstream occlusion condition. The separation of one or more posts are not visible to the end user. An over or under infusion may lead to injuries requiring medical intervention.
Affected products
Alaris Pump Module Model 8100
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
8100LVP
Companies
- Manufacturer
-
Carefusion 303, Inc.
10020 Pacific Mesa Blvd.
San Diego
92121-2733
UNITED STATES