CareFusion Recalls Alaris Pump Module 8100 Due to Latch Design Risk
CareFusion 303, Inc. is recalling 35,940 Alaris Pump Module model 8100 units in the US and Canada due to a potential risk of unintended flow caused by the sear door latch design.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with a potential risk of unintended flow, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
CareFusion 303, Inc. is recalling 35,940 units of the Alaris Pump Module model 8100. The recall covers pumps manufactured between June 2002 and June 2004 that were distributed in the United States and Canada.
The recall is being issued because of a potential risk that could cause unintended flow in the older, centered sear door latch design. This defect is specific to the older latch design found in the affected modules.
Notification will be distributed to all Alaris Pumps customers who have pumps manufactured within the specified date range. Customers should contact CareFusion 303, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Alaris Pump Module model 8100
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Pump
- Hazard
- Affected units
- 35,940
Distribution
Distribution scope not specified by the agency.
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