Hospira Issues Important Safety Information for Blood Sets
Tue, 13 Aug 2013 18:03:00 -0400
FOR IMMEDIATE RELEASE - August 13, 2013 - Hospira, Inc. (NYSE: HSP), announced today a recall of certain blood sets. There have been reports from customers of instances in which the outer wall of blood bags were punctured with the piercing pin on certain Hospira blood sets during insertion of the pin into the blood bag. The root cause has been identified as the design of the new International Organization for Standardization (ISO)-compliant pin, which has a sharp point that can sometimes pierce the wall of non-ISO-compliant blood bags. Hospira distributed an Important Safety Information Letter to customers regarding this issue in April 2013. The U.S. Food and Drug Administration (FDA) has now classified the action as Class I recall, necessitating this notice.
Hospira blood sets are used for the administration of blood and blood products. If the piercing pin on this product punctures the outer wall of a blood bag, it may result in spillage of the blood and blood products stored in the bag, resulting in a delay/interruption in therapy. Spillage of blood products has the potential to cause exposure to the healthcare professional. The severity of the delay/interruption in therapy is dependent upon the underlying condition of the patient. Delay/interruption in therapy can potentially lead to significant injury or death. This issue has been identified as a contributing factor in one report of a patient death due to a delay/interruption in therapy.
The impacted list numbers are: 14200-04-28 Secondary Blood Set; 14203-04-28 Blood Set; 14206-04-28 Y-type Blood Set; 14207-04-28 Blood Set; 14210-04-28 Plum™ Blood Set; 14211-04-28 Plum Blood Set; 14212-04-28 Plum y-type Blood Set, 14217-04-28 y-type Blood Set and 14219-04-28 Y-type Blood Set. These sets were distributed July 2011 through February 2013.
At this time, there is no need for customers to discontinue use of or return Hospira blood sets. Hospira recommends users exercise extreme caution when piercing blood bags with a Hospira blood set mentioned above. Make sure that all instructions for use included with the blood bag and your facility’s protocol for spiking blood bags are completely followed in order to minimize the possibility of puncturing the outer wall of the blood bag.
Hospira has begun distribution of sets with a blunter piercing pin that is shorter than the pins in the Impacted List Numbers. These sets became available in March 2013. Customers should contact Hospira or their local representative for information about these sets. At this time, Hospira is not initiating a recall of the Impacted List Numbers.
For a copy of the important safety information letter call Stericycle at 1-866-608-3936 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
Facilities that experience this issue should contact Hospira at 1-800-441-4100 between the hours of 8 a.m. and 5 p.m. CT Monday through Friday, or email ProductComplaints@hospira.com.
For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187. This phone number is available 24 hours a day, seven days a week.
Any adverse reactions or quality problems experienced with the use of this product may be reported to the U.S. Food and Drug Administration's (FDA) MedWatch Adverse Events Program either online, by regular mail or by fax.
Regular mail: use postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatch/getforms.htm
Hospira, Inc. is the world's leading provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 16,000 employees. Learn more at www.hospira.com.
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