Medical device manufacturer, Hospira, Inc., recently distributed an Important Safety Information Letter concerning specific blood kits over reports that, in some cases, the outer walls of the blood bags, which are in the blood kits, were punctured with the piercing pin, also included the impacted blood sets. Puncture occurred during insertion of the pin into the bag, according to the U.S. Food and Drug Administration (FDA).
The agency deemed the action a Class I recall, which means that this involves a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. The Class I designation followed a report of at least one patient death that was partly due to a treatment delay caused by a punctured blood bag, according to MassDevice.com.
The cause of the problem was identified and appears to involve the design of the new International Organization for Standardization (ISO)-compliant pin. The pin has a sharp point that may pierce the blood bags’ walls, which are considered non-ISO-compliant
Hospira blood sets are used in the administration of blood and blood products. If the product’s piercing pin punctures the blood bag’s outer wall, the blood and blood products, which are stored in the bag, may spill. This spillage may then lead to a delay or interruption in therapy and may lead to the healthcare professional being exposed to that blood.
In its warning letter, Hospira indicated that, a “Delay in therapy has a worst case potential to result in significant injury or death.” The severity of that delay or interruption depends on the patient’s underlying condition. The problem has been associated with a report of one patient death involving a therapy delay or interruption.
The sets were distributed from July 2011 through February 2013 and include the following Impacted List Numbers products:
- 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
- 14219-04-28 Y-type Blood Set
The FDA’s release indicated that customers need not discontinue use of the recalled Hospira blood sets or return the products; however, Hospira recommends users exercise extreme caution when piercing blood bags in the recalled Hospira blood sets. Hospira also recommends the instructions for use included with the blood bag, as well as health care facility protocol for spiking blood bags, are followed to ensue that the potential for puncturing the blood bag’s outer wall is minimized. Hospira began distributing sets with a blunter piercing pin, that is shorter than the pins in the recalled sets, around March 2013.
Hospira indicated that it is not initiating a recall of the Impacted List Numbers products and advised that customers contact Hospira for information about these sets. A copy of the Important Safety Information Letter can be obtained from Stericycle at 1.866.608.3936 from 8:00 a.m. to 5:00 p.m. Eastern Time, Monday through Friday. Facilities may contact Hospira at 1.800.441.4100 from 8:00 a.m. to 5:00 p.m. Central Time, Monday through Friday or by email to ProductComplaints@hospira.com. Hospira Medical Communications may be reached at 1.800.615.0187, which is available 24 hours a day, seven days a week.
