Recall Z-0384-2017— Teleflex Medical

Name: FDA recall Z-0384-2017
Creator: U.S. Food and Drug Administration
Published: 2016-10-27

Class II · Terminated

Class II FDA medical device recall by Teleflex Medical, initiated 2016-10-27, terminated 2020-09-25. It names one FDA 510(k) clearance: K153470. 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.. Reason: Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication..

Recalling firm: Teleflex Medical
Classification: Class II
Status: Terminated
Initiated: 2016-10-27
Terminated: 2020-09-25
Firm location: Research Triangle Park, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K153470 — MADgic Laryngo-Tracheal Mucosal Atomization DeviceTeleflex Medical·cleared 2016-08-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Data sourced from openFDA. This site is unofficial and independent of the FDA.