Skip to content

The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly… recallZ-1791-2009 · Cardinal Health 303 dba Cardinal Health · initiated Jun 12, 2009

Terminated All recalls posted in August 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cardinal Health 303 dba Cardinal Health or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Affected Unit: Alaris PC Unit (Models 8000 and 8015) with software a versions 8 and above when used with the Alaris PCA module (Model 8120) There is a potential risk of over infusion related to a warning message on the user interface of the Alaris PC unit when used in conjunction with the Alaris PCA module. When the Alaris PC unit detects a programmed infusion for the Alaris PCA module that exceed

FDA root cause category: Device Design

What the company is doing

The recall was initiated on June 12, 2009 with the firm forwarding via UPS an Urgent: Medical Device Recall Notification with attached Customer Response Card to the Chief Administrative Officer, Director of Pharmacy, Director of Biomedical Engineering, Director of Nursing & Director of Risk Management of all of the affected consignees. Customers were also asked to please promptly complete and return the enclosed Customer Response Card to expedite the correction process. The Recall Notification informed the consignees of: (A) PROBLEM #1: Occlusion Warning Message for Alaris Pump Module; (B) PROBLEM #2 Syringe volume Warning Message for Alaris PCA module; (C) PROBLEM #3 Electrostatic Discharge (ESD) protection circuitry; (D) PROBLEM #4 Fluid Ingress and (E) PROBLEM #5 Alaris System Inter-Unit Interface (IUI) Connectors Labeling. The recall notice included "Required Action for Users & Follow-up actions by Cardinal Health for all five problems. Customers were also asked to report any adverse reactions experienced with the use of this product, and/or quality problems to the FDA's MedWatch Program. In addition, customer were provided the following contact information for the recall: (1) Cardinal Health Recall Center for general questions: By phone at 1-888-562-6018 7am to 5pm (Pacific) ; (2) Customer Advocacy for adverse reports: By phone at 1-800-854-7120, Option 1, Option 1, Option 3 or by email at [email protected] 24 hours a day, Sunday-Saturday; (3) Technical Support for Technical Questions regarding the Alaris System: By phone at 1-888-562-6018, 6am-5pm (Pacific). The firm followed-up with the release of a nationwide press statement regarding this issue on July 29, 2009. The press release indicated serial numbers of affected devices, as well as CareFusions short term instructions to customers, and the firms strategy to fix the affected devices can be found at: www.cardinalhealth.com/alaris/medical-device-recall/ (This informatio

Recall details

Recall number
Z-1791-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jun 12, 2009
Posted by the FDA
Aug 3, 2009
Recalling firm
Cardinal Health 303 dba Cardinal Health
Quantity
186,000 units
Product code
FRN
FDA submissions
K012383, K051641
Distribution
Worldwide Distribution -- US (including Puerto Rico and Guam), Germany, England, Canada, Netherlands, Malaysia, Singapore, Australia, and New Zealand.

Product description

The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the Alaris PCA Module (Model 8120). The Alaris PC Unit is the central programming and power supply component for the Alaris System modules.

Code information (models, lots, serial numbers)

Model Numbers 8000 and 8015 software version 8 and above when used with the Alaris PCA Module (Model 8120).

Other devices under the same FDA submission

1 device cleared under K012383, K051641 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 52119).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page