Recall Class: Class I
Date Recall Initiated: February 3, 2014
Devices: GemStar Power Supply, 3VDC
|GemStar Power Supply||List Number|
|Wall Mount Power Supply||13026-05|
|Desk Top Power Supply||13072-05|
See recalled list and lot numbers (including foreign distribution lot numbers)
- Manufacturing Dates (U.S.A. only):
- List 13072-04-05 - Oct. 2011 through March 2013
- List 13026-04-05 - Jan. 2013 through March 2013
- Distribution Dates (U.S.A. only.):
- List 13072-04-05 - Nov. 2011 through April 2013
- List 13026-04-05 - Feb. 2013 through April 2013
Use: The GemStar Supply is an accessory that provides power to the GemStar Infusion Pump. The power supply converts alternating current (AC) voltage of 120 or 240V to Direct Current (DC) voltage of 3.3 Volts.
Hospira GemStar Infusion Pumps are used to deliver controlled amounts of fluids including medicines, blood, blood products, nutritional foods, and other mixtures, into a patient’s body in controlled amounts. Hospira Gemstar Infusion Pumps are used in hospitals, for outpatient care, and for home care.
275 N. Field Drive
Lake Forest, Illinois 60045
Bridge Power Corporation
Guang Shou Lu/Dong Shou
China 26440 0000
Reason for Recall:
The power supply may not properly deliver electric power to the GemStar Infusion Pump. If the power supply fails, planned infusion therapy may be delayed if a backup power supply is not used. The firm noted that all 13,002 units distributed worldwide, with 5,687 of those units distributed in the U.S., may fail.
Hospira received a total of 20 reported incidents including one report of smoke and found that the GemStar Infusion Pump was operating on battery power while connected to the 3VDC power supply. There were no reports of injuries or death.
In oxygen-rich environments, an electric shock or spark from a malfunctioning pump could cause a fire.
The use of the recalled devices may cause serious health risks, including delay in therapy, delivery of too much fluid, too high or too low blood pressure, slow or fast heart rhythm/beat, shock, trauma, 1st or 2nd degree burns, smoke inhalation, problems breathing, stroke, and death.
|Hospira Contact||Contact Information||Areas of Support|
|Hospira Global Complaint Management||1-800-441-4100 (M-F, 8 am-5 pm, Central Time
|To report adverse events or product complaints|
|Hospira Advanced Knowledge Center||1-800-241-4002, option 4
(Available 24 hours a day/7 days a week)
|Additional information and technical assistance|
FDA District: Chicago District Office
More Information about this Recall:
Hospira sent an “Urgent Medical Device Correction” letter dated February 3, 2014 to all direct customers. The letter outlined the problem and the steps to be taken. The letter included instructions for how to handle and use the power supplies to lessen the chance of any device failures including the following precaution:
- Avoid arcing, wiggling, or dropping the power supply on hard surfaces. Doing so may result in internal damage that would stop the power supply from working.
Customers who have this product in their inventory should:
- Inform potential users in their organization about the “Urgent Medical Device Correction” letter.
- Complete the reply form attached to the “Urgent Medical Device Correction” letter and return it to the fax number or e-mail address on the form (even if you do not have any recalled product in inventory).
- Inform customers of the recall and ask them to contact Stericycle at 1-888-641-9735 to receive a reply form.
- Remove the power supply from service, if you (or a potential user) believe that the power supply is damaged for any reason. Contact Hospira Global Complaints at 1-800-441-4100 to report the concern.
The letter also states that there is no need to return fully functional power supplies (unless they malfunction).
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.