Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module
FDA Recall Z-0492-2011 · Posted None
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Recalling FirmCareFusion Corporation
Recall StatusTerminated
Product CodeFRN
Date Initiated2010-08-02
Date Terminated2013-07-25
Product Quantity94,146 units
Reason for Recall
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
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
Nationwide in the United States, Canada, Mexico, and the European Union
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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