Medical Device Safety and Recalls: Merit Medical Systems, Custom Procedural Trays/Kits Containing 1% Lidocaine HCl Injection, USP, 10mg/mL - Particulates Found in Hospira supplied 1% Lidocaine HCl

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Merit Medical Systems, Custom Procedural Trays/Kits Containing 1% Lidocaine HCl Injection, USP, 10mg/mL - Particulates Found in Hospira supplied 1% Lidocaine HCl

Hospira, Inc. is recalling one lot of 1% Lidocaine HCl Injection which is contained in the Custom Procedural Trays/Kits. These trays/kits were recalled due to one confirmed customer report of visible particulate, identified in the primary product container, in the form of dark red/black particles.  The particulate was identified as oxidized stainless steel. If oxidized stainless steel particulate is undetected, there is a potential to be injected and/or result in delay in therapy. These effects have the potential to result in serious life-threatening complications requiring medical intervention.  For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm389080.htm

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