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Important Safety Information on Hospira Devices that have Defective AC Power Cords
- Starting date:
- September 25, 2009
- Posting date:
- October 1, 2009
- Type of communication:
- Dear Healthcare Professional Letter
- Medical Device
- Source of recall:
- Health Canada
- Healthcare Professionals
- Identification number:
This is duplicated text of a letter from Hospira Healthcare Corporation.
Contact the company for a copy of any references, attachments or enclosures.
Health Canada Endorsed Important Safety Information on Hospira Devices that have Defective AC Power Cords
September 25, 2009
Subject: Medical Device Recall for certain Hospira devices that have defective AC power cords
Dear Health Care Professional,
Hospira is conducting a 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 outside Canada 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. Hospira has not received any reports of serious patient harm related to the situation.
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). Devices with power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected (see Figure 2). Electri-Cord has identified the root cause of the issue and has implemented necessary design changes to reduce the likelihood of recurrence.
Hospira recommends you take the following immediate actions to locate affected AC power cords:
- Check all affected devices and spare parts inventory to determine if the specified AC power cords are in use at your facility (see Figure 1).
- For affected power cords not exhibiting any of the characteristics described above, please continue to monitor those power cord plugs closely until you receive replacement power cords. Should you have any Clinical questions, please do not hesitate to contact Clinical Support at 1-866-488-6088, option 4.
- For affected AC power cords, inspect for any bent or cracked prongs and bridge connection, burnt plastic, or excessive wear and tear.
- For those cords exhibiting bent or cracked prongs and/or bridge connection, burnt plastic or excessive wear and tear, please immediately discontinue use and contact Hospira Technical Support at 1-866-488-6088, option 5. Hospira will contact your facility to schedule replacement activities in the very near future.
Hospira is not asking that you immediately return affected power cords or devices. Service activities will begin in an expedious matter, and will continue until all replacement activity is complete. Hospira will replace all affected power cords regardless of their condition. Hospira will provide replacement cords and resources to assist with replacement upon request.
Please complete and return the attached Reply Form after your facility has completed its review for affected AC power cords.
Please forward this notice to all departments within your facility using devices with Electri-Cord power cords and to any third parties to whom your facility may have sold or shipped Hospira devices with affected power cords.
This correction is being made with the knowledge of Health Canada.
|Product Name||List Number|
|LIFECARE PCA 4100 PLUS INFUSER||1950|
|LIFECARE 5000 PLUM INFUSION PUMP SYSTEM||2507|
|PLUM XL 3 MULTI-LINE INFUSION SYSTEM (XL3)||11781|
|PLUM XL 3 MICRO/MACRO INFUSION SYSTEM (XL3M)||11845|
|PLUM XL MICRO/MACRO INFUSION SYSTEM (XLM)||11846|
|PLUM XL MICRO/MACRO INFUSION WITH DATA PORT (XLD)||11859|
|PLUM A+ VOLUMETRIC INFUSION PUMP||11971 / 12391|
|LIFECARE PCA 3 INFUSION SYSTEM||12384|
|PLUM A+3 INFUSION PUMPS||12618|
|PLUM A+3 INFUSION PUMPS WITH MEDNET||20678|
|PLUM A+ VOLUMETRIC INFUSION PUMP||20679 / 20792|
|LIFECARE PCA 3 INFUSION SYSTEM||20709|
|GEMSTAR AC WALL ADAPTER||13072|
|GEMTAR DOCKING STATION||13075|
|NUTRIMIX MICRO COMPOUNDERN||11365|
|OMNI-FLOW 4000 PLUS IV MEDICATION MANAGEMENT SYSTEM||40051|
|OPTIONAL THERMA PRINTER||50132|
|OXIMETRIX 3 SYSTEM S02/CO COMPUTER||50130|
Figure 1: Affected Plug.
Affected cords contain a prong and ground-pin insert design, which can be identified by a black plastic bridge connecting the terminal prongs on the plug.
Figure 2: Not Affected Plug.
Power cords that do not have a black bridge connecting the terminal prongs on the plug are not affected.
Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious specific adverse incident or other serious adverse incidents in patients using Hospira devices that have defective AC power cords should be reported to Hospira Healthcare Corporation or Health Canada at the following addresses:
Hospira Healthcare Corporation
1111 Dr.-Frederik-Philips Boulevard, Suite 600
Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Telephone: The Inspectorate Hotline 1-800-267-9675
The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.
For other inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate (MHPD)
original signed by
Director, Scientific Affairs
Hospira Healthcare Corporation
Urgent Device Recall for AC Power Cords
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1. Are there additional locations or entities that may have received the affected cords?
If yes, please list the contact information below and Hospira will notify them directly.
- Contact Name:
2. I would like to request Hospira resources to replace my detachable cords.
Hospira will contact you for service scheduling in the near future
3. I have identified any Hospira devices that have AC power cords which were replaced with non-Hospira supplied cords.
- Number of Cords:
- Please explain:
4. Page numbers being faxed back:
- Replacement Cord(s) Ship to:
- Firm/Facility Name:
- Hospira Customer #:
- Contact Name:
- Reply Form Completed By:
- Printed Name:
Please fax 5 pages of the completed form to Hospira at 1-877-906-0208
Urgent Device Recall for AC Power Cords
Reply Form - August 26, 2009
AC Power Cords manufactured by Electri-Cord Manufacturing Corp. on the following Hospira Devices:
Please fax all 5 pages of the completed form to 1-877-906-0208
Hospira will provide replacement cords and resources to assist with replacement upon request. To assist in expediting this process, please check your inventory and complete the information below. The product identity label located on the back of the device will contain the applicable list number referenced below.
|Product Description||List Number||Number of Out of Service, Affected Cords for Immediate Replacement||Number of In use (monitoring), Affected Cords for Replacement|
|GemStar AC Wall (Mains) Adapter (90-260 Volts-universal)||13072-04-01|
|GemStar Docking Station (90-260 Volts)||13075-04-01|
|LifeCare PCA Plus II||01950-04-01|
|LifeCare PCA 3||12384-04-05|
|LifeCare PCA with Hospira MedNet||20709-04-03|
|Nutrimix Micro Compounder||11365-04-01|
|Omniflow 4000 Plus||826-85559-003|
|Optional Thermal Printer (For use with Model 3300 COC), Oximetrix 3 SO2/CO Computer, Q-Vue CCO Computer and Q2 CCO/SO2 Computer||50132-04-05|
|Oximetrix 3 SO2/CO Cardiac Output Computer||50130-04-07|
|Plum LifeCare 5000 (Plum1.6) with dataport||02507-04-01|
|Plum A+ v.11.X||12391-04-01|
|Plum A+ v.10.3||11971-04-01|
|Plum A+3 v.11.X||12618-04-01|
|Plum A+3 Infusion System with Hospira MedNet||20678-04-01|
|Plum A+ Infusion System with Hospira MedNet||20679-04-03|
|Plum XL 3||11781-04-01|
|Spare Part Inventory (Replacement Cords)||826-85559-003|
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