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Hospira voluntary recalls certain lots of several LifeCare products due to potential for leakage.
FDA is reporting that Hospira has issued a voluntary nationwide recall of certain lots of the company’s LifeCare line of flexible intravenous solutions due to the potential for leakage. Hospira identified the potential problem during re-inspection of a manufactured product lot in which a single puncture mark was identified going through the overwrap and primary container. The affected lots were originally distributed by Hospira to direct accounts from September 2013 through October 2014.
According to FDA, this puncture may result in leakage that is difficult to detect, resulting in an open system with the potential for contamination, compromised sterility, drug waste, spillage, inadequate or inconsistent solution/medication dosing, and/or delay in therapy. Hazardous topical exposure may occur if a hazardous drug is added to the flexible container. The products’ packaging insert recommends that the solution only be administered if the solution is clear and the container is undamaged.
Hospira has attributed the root cause to a defect in a conveyance system, and FDA says corrective actions have been implemented to prevent a reoccurrence. No reports of adverse events associated with the impacted lots have yet to be reported.