[UPDATE 08/14/2013] Recall classified as Class I.
AUDIENCE: Health Professional, Risk Manager
ISSUE: Hospira, Inc. announced 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. 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. 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.
The root cause of the punctures 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.
BACKGROUND: Hospira blood sets are used for the administration of blood and blood products. Hospira distributed an Important Safety Information Letter to customers regarding this issue in April 2013.
RECOMMENDATION: At this time, there is no need for customers to discontinue use of or return Hospira blood sets. However, Hospira recommends users exercise extreme caution when piercing blood bags with a Hospira blood set mentioned above and make sure that all instructions for use included with the blood bag and 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 which came available in March 2013. Customers should contact Hospira or their local representative for information about these sets.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178