FDA has assigned its most serious recall designation to Intravascular Administration Sets from Hospira (Lake Forest, IL). The reason behind the recall is that the piercing pin has been found to have the risk of poking a hole in the outer wall of blood bags, potentially leading to blood loss or delay of therapy, and exposing clinicians to blood. The problem has been associated with the design of an ISO-compliant pin, which can pierce walls of non-ISO-compliant blood bags.
The product has been linked to one patient death whose therapy was delayed because of the problem.
It is not the only recent Class I recall for Hospira. In May, FDA gave that designation to the company’s GemStar Infusion System, which reportedly has battery problems that can result in power loss.
FDA has also pointed out manufacturing problems in the company’s facility based in Rocky Mount, NC. The company recently announced it was working to resolve a variety of manufacturing problems in that and other facilities located across the globe. "While we continued to make progress in supply recovery and in advancing our quality-improvement initiatives, we still have work to do to reinforce our foundation," the company’s CEO F. Michael Ball.
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