Cardinal Health Alaris is recalling all Alaris Medley Infusion Pumps shipped before September 27, 2007. The recall affects all Medley Pump Model 8100.
The recall stems from reports of inaccurate flow rates. The problem which has been identified by Cardinal Health is caused by the occluder springs, which control medication flow, may have been misassembled during manufacturing or servicing. Misassembled springs can lead to overinfusion, which could result in serious health consequences or death.
The company says that overinfusion may be difficult to detect because the misassembled springs can work intermittently, and there’s no warning or notification when an overinfusion does occur.
Additional Information can be obtained via the FDA Access Data Site
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