Alaris Pump Module 8100 Recalled for Bent Connector That May Disable Device
CareFusion is recalling approximately 192,964 Alaris Pump Module Model 8100 infusion pumps that may have bent female connectors preventing device operation and delaying patient treatment.
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 critical medical equipment (infusion pump). The bent connector represents a clear functional defect that could prevent operation and delay necessary treatment. No injuries or illnesses have been reported, which aligns with the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CareFusion 303, Inc. is recalling the Alaris Pump Module Model 8100, a modular infusion pump and monitoring system. The affected devices may have a bent female IUI connector.
The bent connector may render the device inoperable, potentially causing delays in the start of infusion or patient monitoring. Delays in starting necessary infusions could affect patient care.
Approximately 192,964 units are involved in this recall. Distribution is worldwide, including throughout the United States (all 50 states, District of Columbia, Puerto Rico, and Guam) as well as Australia, Belgium, Canada, Hungary, Kuwait, New Zealand, Qatar, Saudi Arabia, Singapore, Taiwan, and the United Arab Emirates.
Devices are identified by Model Number 8100 and UDI-DI codes 10885403810046, 10885403810039, or 10885403810015.
The recalled product
- Product
- Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- bent-connector
- device-malfunction
- treatment-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 (2)
- Model Number: 8100 UDI-DI code: 10885403810046
- 10885403810039
Distribution
Distributed nationwide across the United States.
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