The Recall Desk
HighFDA (Devices)·Z-2700-2017·Announced 2017-07-19

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.

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 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.

Related recalls

Same manufacturer · CareFusion 303, Inc.

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