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Hospira announced a voluntary recall of various lots of several intravenous (IV) solutions in its LifeCare line due to potential for leakage.
This recall is following the discovery of a single puncture mark going through the overwrap and primary container during a re-inspection of a product lot. The primary cause has been identified as a conveyance system defect, and corrective actions have been set in place to prevent future incidences.
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The puncture can lead to a leakage that is difficult to detect. Leakage may result in an open system, which has increased potential for contamination, unsterility, drug waste, spillage, inadequate or inconsistent solution/medication dosing, and/or therapy delay. Further, harmful topical exposure can occur if a hazardous drug were to enter the flexible container.
The affected lots were distributed between September 2013 and October 2014. The full list of recalled products are found here. Anyone with existing inventory should stop use and quarantine the product immediately.
For more information call (844) 861-6221 or visit FDA.gov.
