Rappel de Alaris

Recall

56405

Class 2

Z-0492-2011

2010-08-02

Terminated

United States

2013-07-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93511

Than recall was initiated because carefusion has identified identified a potential risk associated with the alaris pc unit formerly known as medley pc unit (pc unit) model 8000 only when used with alaris pump module (pump module) or alaris syringe module' (syringe module), this recall notification details the potential risk and recommended steps for users to take if they encounter a specific pc.

CareFusion will send by registered return receipt mail the customer notification letter to all customers using the affected Alaris PC Unit beginning August 24, 2010. The customer notification letter will be addressed to the Directors of Nursing, Risk Management, and Biomedical Engineering. Customers will be required to confirm receipt of the notification by returning the Recall Response Card to CareFusion by postage-paid, selfaddressed mail, fax or email. The recall notice informed the customers of the reason for the notice, the units affected, the potential risk, a step-by-step description of the issue and the required actions for users. The customers were also told that CareFusion is working to release a software update to address this display error and will contact your facility as soon as the software update is available. CareFusion does not require that you return your devices. Clinicians should weigh the risk/benefits to the patients before continuing the use of the device. Customers were also told that any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program. The recall notice provided contact information for CareFusion's Recall Center, Customer Advocacy and Technical Support units.