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Hospira Warns of Complications with Blood Sets Following Patient Death

Filed August 20th, 2013 Joshua Sophy

Hospira Inc. has issued a warning to its customers about the delicate nature of blood bags when its Hospira Blood Sets are used.

The warning follows the death of a patient who received a delayed blood therapy because the pin on the Hospira Blood Set pierced the blood bag and rendered it unusable. Hospira says there is no need to issue a recall on its Hospira Blood Sets but does warn users of the device to use “extreme caution” when introducing the pin to a blood bag.

Hospira identified the following List numbers of its Blood Kits affected by the warning: 14200-04-28, 14203-04-28, 14206-04-28, 14207-04-28, 14210-04-28, 14211-04-28, 14212-04-28, 14217-04-28, and 14219-04-28.

Hospira said in a warning letter that it had received reports of people puncturing the outer wall of blood bags when they’re using the affected Hospira Blood Sets. The sets included in this warning were distributed from Hospira between July 2011 and February 2013. Hospira does not know why the pins on these specific Blood Sets are causing more trouble than others.

If a patient is in severe need of a blood treatment and a caretaker must delay that therapy because the pin on these Hospira Blood Sets has pierced the outer wall of the blood bag, it could result in death for the patient. Serious injuries could also result, depending on the condition of the patient in need of the blood. Caretakers are also at risk of exposure when they pierce a blood bag with one of these defective products.

For these reasons, Hospira’s safety action is being treated by the U.S. Food and Drug Administration like a Class I recall, which is reserved for only the most potentially dangerous products.

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