FDA MedWatch - LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage

AUDIENCE: Pharmacy, Nursing, Risk Manager

ISSUE: Hospira, Inc. announced the voluntary recall of certain lots of several products in its LifeCare line of flexible intravenous solutions 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. Hazardous topical exposure may occur if a hazardous drug is added to the flexible container. To date there have been no reports of adverse events associated with this issue for the impacted lots.

BACKGROUND: The affected lots were originally distributed by Hospira to direct accounts from September 2013 through October 2014. The root cause 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.

RECOMMENDATION: See the Firm Press Release for a list of the recalled lots. Anyone with an existing inventory of the recalled lots should stop use and distribution and quarantine the product immediately. Hospira will be notifying its direct customers via a recall letter and will arrange for impacted product to be returned to Stericycle. For additional assistance, call Stericycle at 1-844-861-6221 between the hours of 8am to 5pm ET, Monday through Friday.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the complete MedWatch safety summary including a link to the firm press release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm418887.htm