The FDA issued a Class I recall on blood kits made by Hospira (NYSE:HSP) after the medical device company reported that at least 1 patient’s death was partially due to a delay in treatment caused by a punctured blood bag.
The company warned healthcare providers that the piercing pins in certain of its blood kits may pierce through the blood bag’s outer wall, leading to blood leaks and exposing healthcare providers to blood products.
Hospira maintains that there is no need for customers to stop using their products, and the company has not issued a recall. Hospira is currently handing out blunter and smaller piercing pins so that healthcare providers may continue to use the blood bags safely, according to the recall notice.
The FDA’s Class I recalls are reserved for product issues with the potential to cause the most serious adverse events or death. Hospira issued a letter to customers, advising providers to carefully follow protocol for spiking blood bags.
"If the piercing pin of this product punctures the outer wall of a blood bag it may result in spillage of the blood products stored in the bag resulting in a delay in therapy," the company wrote. "A delay in therapy has a worst-case potential to result in significant injury or death."