Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:31326
Brand Name:Alaris System Infusion Pumps_CFN San Diego
Model:BD Alaris™ Pump Module Model 8100
Affected:Product Codes: 10930270, 12278595, 8100ADXEN917, 8100DXEN91177, 8100BDADXEN933, 8100BDADCEN933, 8100BDNDXEN933, 8100BDAIXEN121, 8100BDAIXEN1211.
Software version:
Recalling Organisation:Becton Dickinson Ltd
Unit 4 / 110 Mays Road
Onehunga
Auckland 1061
Contact Information:0800 572 468
Manufacturer:CareFusion 303 Inc
Issue:the manufacturer has identified that the Pump Module Pivot Latch Screw may back out if the pivot latch screw is not used according to labelling inclusive of user manual and technical service user manual. Specifically, if it is reused (retightening), improperly installed (improper torque used when tightening), or if an unauthorized (third party part) Pivot Latch Screw is used.
A backed-out Pivot Latch Screw can lead to rate inaccuracies by not allowing the door to fully close due to interference between the backed-out Pivot Latch Screw and adjacent devices.
Recall action type:Correction
Recall action:Product to be modified
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:26/6/2023
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