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 II||Plum XL 3||Oximetrix 3 SO2/CO Cardiac Output Computer|
|LifeCare 5000 with DataPort||Plum A+ v.10.3||Model 3300 Cardiac Output Computer|
|LifeCare PCA with Hospira MedNet||Plum A+ Infusion System with Hospira MedNet||Nutrimix Micro Compounder|
|LifeCare PCA 3||Plum A+3 v.11.3||Acclaim Encore Infusion Pump|
|LifeCare Model 4 infusion pump||Plum LifeCare 5000 (Plum 1.6) with dataport||GemStar AC Wall (Mains) Adapter (90-260 Volts-universal)|
|LifeCare 4200 PCA plus Infuser with Microgram delivery||Plum A+3||GemStar Docking Station (90-260 Volts)|
|Plum XL3M||Plum A+3 v.11.5||Optional Thermal Printer (For use with Model 3300 COC, Oximetrix 3 SO2/CO Computer, Q-Vue CCO Computer and Q2 CCO/SO2 Computer)|
|Plum XLM||Plum A+3 Infusion System with Hospira MedNet||Omniflow 4000 Plus|
|Plum XL||Plum XL Infusion System||Flexiflo Quantum Enteral Pump|
|Plum XLD||Q2 Plus SO2/Continuous Cardiac Output Computer||Q2 Continuous Cardiac Output (CCO)/SO2 Computer|
|Plum XL3M with Dataport||Q2 CCO/SvO2 Monitoring System||QVue 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
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
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.