Alaris System Inter-Unit Interface (IUI) Connectors. The… recallZ-1794-2009 · Cardinal Health 303 dba Cardinal Health · initiated Jun 12, 2009

Why it was recalled

There is a potential risk of IUI connector failure in the Alaris System when these connectors become corroded or contaminated, which may result in an interruption of infusion with an audible and visual alarm. IUI connectors can become corroded or contaminated when exposed to fluid spills or improper cleaning. This notification is to reinforce the importance of inspection of IUI connectors prior

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-1794-2009

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

500,000 units

Product code

FRN

FDA submissions

K012383, K023264, K032233, K051641, K950419

Distribution

Worldwide Distribution -- US (including Puerto Rico and Guam), Germany, England, Canada, Netherlands, Malaysia, Singapore, Australia, and New Zealand.

Product description

Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Alaris PC Unit, Model Numbers 8000 and 8015; Alaris Pump Module, Model 8100; Alaris Patient-Controlled Analgesia (PCA), Model 8120; Alaris Syringe Module, Model 8110; Alaris SpO2 Module, Model 8210 and 8220 and Alaris EtCO2 Module, Model 8300.

Other devices under the same FDA submission

4 devices cleared under K012383, K023264, K032233, K051641, K950419 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• Alaris 8100

  Carefusion 303, Inc. · Pump, infusion
  2 recalls2 deaths650,218 reports
• Alaris 8015

  Carefusion 303, Inc. · Pump, infusion
  2 recalls45 deaths148,093 reports
• Alaris 8110

  Carefusion 303, Inc. · Pump, infusion
  2 recalls4 deaths21,956 reports
• Alaris 8110

  Carefusion 303, Inc. · Pump, infusion
  2 recalls2 deaths15,547 reports

Other products in the same recall event

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

• Z-1790-2009 · Terminated
  The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software version 4 and above.
• Z-1791-2009 · Terminated
  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…
• Z-1792-2009 · Terminated
  The Alaris PC Unit, Model 8015 (manufactured or serviced between April 2008 and January 2009). The Alaris PC Unit is the central programming and power supply component for the Ala…
• Z-1793-2009 · Terminated
  Alaris Pump Module, Model 8100.