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May 05 - 07 2014, 12:00 AM - 12:00 AM

2014 ASA Legislative Conference

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FDA MEDWATCH ALERTS

March 28, 2014

FDA Update on the Shortage of Normal Saline

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FDA Update on the Shortage of Normal Saline

March 18, 2014

FDA MedWatch - Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine

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Merit Medical Systems Custom Procedural Trays Kits Recall Particulates Found in Hospira Lidocaine

March 18, 2014

McKesson Technologies Anesthesia Care: Recall - Patient Case Data May Not Match Patient Data

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McKesson Technologies Anesthesia Care Recall Patient Case Data May Not Match Patient Data

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1 Percent Lidocaine HCL Injection By Hospira: Recall - Presence Of Dark Particulate

Monday, October 07, 2013

AUDIENCE: Health Professional, Risk Manager

ISSUE: Hospira, Inc. announced it has initiated a voluntary nationwide recall of one lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 20 mL Multiple-dose Fliptop Vial, NDC 0409-4276-01 Lot 25-090-DK (the lot number may be followed by 01 or 02). This action is due to one confirmed customer report of visible particulate, identified in the primary container, in the form of dark red/black particles. The particulate was identified as oxidized stainless steel. Depending on the particle size, if undetected, it could block administration of the drug to the patient, causing a delay in therapy. Impact to the patient would depend on the time it would take to obtain a new vial, the condition being treated and the patient’s status.

BACKGROUND: The recall is being conducted as a precautionary measure. The root cause has not been determined and is under investigation. Hospira informed customers of the issue in a letter dated Sept. 16, 2013. This lot was distributed March 2013 through June 2013.

RECOMMENDATION: Anyone with an existing inventory should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-866-364-8812 between the hours of 8am to 5pm ET, Monday through Friday, to arrange for the return of the product. Replacement product from other lots is available. 

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 links to the Firm Press Release at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm370783.htm

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