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

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FDA MedWatch LifeCare Flexible Intravenous Solutions by Hospira Inc

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FDA MedWatch CareFusion EnVe and ReVel Ventilators

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FDA MedWatch ICU Medical ConMed Stat2 Flow Controller

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Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates

Friday, April 18, 2014

AUDIENCE: Risk Manager, Pharmacy, Anesthesiology

ISSUE: Hospira notified the public of a nationwide recall of seven lots of Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL) to the user level due to a glass defect located on the interior neck of the vial. The defect was identified during a sample inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates were also identified in vials upon further analysis.

Injected particulate matter may result in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate. Capillaries, which may be as small as the size of a red blood cell, may become occluded. Chronically, following sequestration, particulate matter may lead to granulomatous formation, most likely in the lungs. Long term clinically meaningful impact is low if a patient has normal lung function. While extremely rare, embedded stainless steel may put a patient at risk from MRI (strong magnetic field exposure) as particulate, if in the lung, could potentially dislodge and be pulled through tissue.

BACKGROUND: The affected lots were distributed nationwide to distributors/wholesalers, hospitals and clinics from August 2013 through December 2013. On April 2, 2014, Hospira notified its customers via recall letter that the company had implemented corrective actions to the manufacturing process to prevent recurrence. See the Press Release for a listing of affected lot numbers.

RECOMMENDATION: Customers have been advised to check inventory and immediately quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Affected product should be returned to Stericycle, which can be contacted at 1-877-272-2158 (M-F, 8 a.m. - 5 p.m. ET).

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 MedWatch safety alert, including a link to the press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm393904.htm

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