CareFusion Recalls BD Alaris Infusion Pump Keypads Due to Fluid Ingress
CareFusion is recalling BD Alaris Infusion Pump Module Keypads and Door Assembly Kits because fluid ingress can cause unresponsive or stuck keys, potentially delaying medication infusion.
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: The recall involves a medical device where a defect can lead to infusion delays or interruptions, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
CareFusion 303, Inc. is recalling the BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad and the Pump Module Door Assembly Replacement Kit with Pump Module Keypad. The affected parts are identified by part numbers 49000239, 49000346, 49000438, and 49000439. The recall covers 160,300 units that were distributed worldwide, including the United States and various international markets.
The recall was initiated because the pump module keypad may lift, allowing fluid to enter the device. This fluid ingress can result in unresponsive keys, which may cause the module to continue infusion without alarming the PC unit, or it may necessitate a different pump module. Additionally, stuck keys may cause the PC unit to alarm and exhibit a Channel Error. These issues may result in infusion start delays, an inability to titrate medication, or infusion interruptions.
The recalled Pump Modules with Keypads were manufactured between January 23, 2019, and December 5, 2019. The Pump Module Door Assembly Kits with Keypads are dated from January 15, 2019, to November 14, 2019. Users should check their devices for these specific part numbers and dates to determine if they are affected.
The recalled product
- Product
- BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Affected units
- 160,300
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)
- Pump Module with Keypad: manufactured January 23
- 2019 to December 5
- 2019. Pump Module Door Assembly Kit with Keypad: Dated from January 15
- 2019 to November 14
- 2019.
Distribution
Distributed nationwide across the United States.
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