Several products in Hospira’s LifeCare line of flexible intravenous solutions were recalled due to the potential for leakage. The issue was identified during re-inspection of a manufactured product lot in which a single puncture mark was identified going through the overwrap and primary container.
The puncture in the primary container may result in leakage that is difficult to detect. Leakage may result in an open system, which has the potential for contamination, compromised sterility, drug waste, spillage, inadequate or inconsistent solution/medication dosing, and/or delay in therapy, all of which may require medical intervention and should be reported to Hospira and/or the FDA. Hazardous topical exposure may occur if a hazardous drug is added to the flexible container. Hospira’s product insert packaged with LifeCare flexible intravenous containers recommends providers do not administer unless the solution is clear and the container is undamaged.
The affected lots were originally distributed by Hospira to direct accounts from September 2013 through October 2014. The root cause of the puncture is attributed to a defect in a conveyance system, and corrective actions have since been implemented to prevent a reoccurrence. The manufacturing issue that caused this incident has been addressed.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication