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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Hospira Issues Urgent Device Recall For AC Power Cords

Contact:
Hospira Technical Support Operations
1-800-241-4002

FOR IMMEDIATE RELEASE -- Lake Forest, Ill. -- August 14, 2009 -- Hospira, Inc. (NYSE: HSP), is initiating a nationwide recall of certain Hospira devices that have defective AC power cords manufactured by Electri-Cord Manufacturing Corporation. This recall is being issued in response to customer reports of sparking, charring and fires on the plug of the power cord. Hospira's investigation of these reports determined that the power cord's prongs may crack and fail at or inside the plug. The potential risks from this power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires which may also occur in an oxygen-rich environment. Depending on the device and therapy, these failures may lead to potential serious injury or death. The products affected by this recall include:

 

LifeCare PCA Plus IIPlum XL 3Oximetrix 3 SO2/CO Cardiac Output Computer
LifeCare 5000 with DataPortPlum A+ v.10.3Model 3300 Cardiac Output Computer
LifeCare PCA with Hospira MedNetPlum A+ Infusion System with Hospira MedNetNutrimix Micro Compounder
LifeCare PCA 3Plum A+3 v.11.3Acclaim Encore Infusion Pump
LifeCare Model 4 infusion pumpPlum LifeCare 5000 (Plum 1.6) with dataportGemStar AC Wall (Mains) Adapter (90-260 Volts-universal)
LifeCare 4200 PCA plus Infuser with Microgram deliveryPlum A+3GemStar Docking Station  (90-260 Volts)
Plum XL3MPlum A+3 v.11.5Optional Thermal Printer (For use with Model 3300 COC, Oximetrix 3 SO2/CO Computer, Q-Vue CCO Computer and Q2 CCO/SO2 Computer)
Plum XLMPlum A+3 Infusion System with Hospira MedNetOmniflow 4000 Plus
Plum XLPlum XL Infusion SystemFlexiflo Quantum Enteral Pump
Plum XLDQ2 Plus SO2/Continuous Cardiac Output ComputerQ2 Continuous Cardiac Output (CCO)/SO2 Computer
Plum XL3M with DataportQ2 CCO/SvO2 Monitoring SystemQVue CCO Monitoring System
Plum A+ Infusion System  

 

Hospira will instruct users of these products to inspect and identify affected power cords on their infusion pumps, compounders, monitoring devices and printers to determine whether their product contains an affected Electri-Cord AC power cord.

Hospira is working with its customers to replace all affected power cords regardless of their condition. Hospira will begin service activity the week of Aug. 16, 2009, and will continue until all replacement activity is complete.

Users with affected power cords that have bent or cracked prongs, burnt plastic or excessive wear and tear should discontinue use immediately and contact their Hospira sales representative or Hospira Technical Support Operations at 1-800-241-4002 (available from 6 a.m. to 4 p.m., Pacific time) for instructions on receiving replacement parts or devices. Users with affected power cords that are not exhibiting any of these characteristics should monitor the power cords regularly and be mindful of excessive wear and tear, misuse or abuse until all affected cords can be replaced. 

This recall is limited to device power cords with a prong and ground-pin insert design, which can be identified by a black plastic bridge connecting the terminal prongs on the plug (see Figure 1 below).

Figure 1: Affected Plug

photo of purple plug with a black plastic bridge connecting the terminal prongs on the plug

Devices with power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected (see Figure 2).

Figure 2: Not Affected Plug

photo of purple plug that does not have a black bridge connecting the terminal prongs on the plug

Electri-Cord has identified the root cause of the issue and has implemented necessary design changes to reduce the likelihood of recurrence.

Hospira has not received any reports of serious patient harm related to the situation.

Hospira Technical Support Operations is available from 6 a.m. to 4 p.m. Pacific time Monday through Friday. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187 between 6 a.m. and 3 p.m. Pacific time.

Any adverse reactions experienced with the use of these products and/or quality problems may also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

About Hospira

Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncology injectables, as well as integrated infusion therapy and medication management solutions. Through its products, Hospira helps improve the safety, cost and productivity of patient care. The company is headquartered in Lake Forest, Ill., and has more than 14,000 employees. Learn more at www.hospira.com.

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