Alaris Syringe Module Model 8110 Infusion Pumps Recalled for Bent Connectors
CareFusion's Alaris Syringe Module Model 8110 infusion pumps are being recalled because affected units may have bent female connectors that can prevent device operation and delay infusions. Approximately 20,145 units have been distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a critical medical device (infusion pump) where a manufacturing defect (bent connectors) may prevent device operation. No illnesses or injuries have been reported in the source, but the potential for delays in necessary infusion therapy represents a risk-of-harm scenario consistent with a High severity rating.
Plain-English summary
CareFusion 303, Inc. is recalling the Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system.
Certain affected units may have bent female IUI (Inter-Unit Interface) connectors, which could render the device inoperable or cause delays in starting infusions or monitoring functions. Approximately 20,145 units have been affected.
The recalled devices were distributed nationwide throughout the United States and internationally to Australia, Belgium, Canada, Hungary, Kuwait, New Zealand, Qatar, Saudi Arabia, Singapore, Taiwan, and the United Arab Emirates. Affected device serial numbers and UDI-DI codes are identified in the recall notice for verification purposes.
The recalled product
- Product
- Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device
- Hazard
- bent-connector
- device-malfunction
- infusion-delay
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Model Number: 8110 UDI-DI codes: 10885403516047
- 10885403515323
- 10885403811043
- 10885403811036
- 10885403811012
Distribution
Distributed nationwide across the United States.
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