Z-2700-2017Class II

Alaris Pump Module model 8100

Name: Z-2700-2017 Alaris Pump Module model 8100
Creator: CareFusion 303, Inc.
Published: 2017-06-12
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2017-06-12 / Terminated / root cause: design

FDA source

CareFusion 303, Inc. began a recall of Alaris Pump Module model 8100 on 2017-06-12. FDA classified it as Class II and gives the reason as "There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2700-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-12
Posted: 2017-06-19
Terminated: 2019-01-28
Recalling firm: CareFusion 303, Inc
Product: Alaris Pump Module model 8100
Product code: FRN Pump, Infusion
Reason for recall: There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Medical Device Recall letter will be sent on 6/12/17 to customers to inform them that BD is issuing this letter to inform you of a potential risk associated with the Alaris Pump module. Firm identified a specific scenario that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100. This scenario is reproducible under the following situations: a) the user does not close the roller clamp on the IV administration set before the pump door is opened as recommended, and b) opening the pump door using an atypical technique with the door latch with the centered sear design. The letter instructs customers If their device has a centered-sear that was manufactured between June 2002 to June 2004, clearly mark and sequester (e.g. Biomed department) the Alaris Pump module that exhibited the issue. Notify CareFusion Customer Advocacy at 888-812-3266 or [email protected] to coordinate an onsite remediation or send the devices to the BD Service Depot.
Quantity in commerce: 35,940 units
Distribution: US and Canada
Product codes and lots: Notification will be distributed to all Alaris Pumps customers with pumps manufactured between June 2002 through June 2004.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2700-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2700-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-07

Product code FRN

K950419Class IIThe Imed Orion Infusion Pump and Administration SetsImed Corp. / cleared 1995-06-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)