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Teleflex Medical recalls LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery o
Recalled December 28, 2016 · FDA recall Z-0384-2017 · Teleflex Medical
Hazard
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. · FDA Class II
Units
2,674,650 units in total
Sold at
Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.
Description
Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.
Product
LMA MADgic, Atomization Device with 3mL Syringe, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.
Manufacturer(s)
Teleflex Medical
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →