The Recall Desk

FDA (Devices) recall action 75554

Teleflex Medical recalled 7 products on 2016-12-28

The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.

Products
7
Announced
2016-12-28
Critical
0
Units
18,722,550

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–7 of 7

  • ModerateFDA (Devices)··2016-12-28

    Teleflex Medical Recalls LMA MADgic Atomization Devices for Spray Defect

    Teleflex Medical is recalling LMA MADgic atomization devices because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.

    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…
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    0 states
  • ModerateFDA (Devices)··2016-12-28

    Teleflex Recalls LMA MADomizer Sprays Due to Inadequate Atomization

    Teleflex Medical is recalling LMA MADomizer devices because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.

    Product
    LMA MADomizer, 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…
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    0 states
  • ModerateFDA (Devices)··2016-12-28

    Teleflex Recalls LMA MADett Endotracheal Tubes for Inadequate Anesthesia Delivery

    Teleflex Medical is recalling LMA MADett endotracheal tubes because they may fail to atomize medication, potentially causing inadequate anesthesia.

    Product
    LMA MADett, Endotracheal tube Mucosal Atomization Device, 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…
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    0 states
  • ModerateFDA (Devices)··2016-12-28

    Teleflex Recalls LMA MADdy Topical Anesthesia Sprays Due to Delivery Defect

    Teleflex Medical is recalling LMA MADdy topical anesthesia sprays because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.

    Product
    LMA MADdy, 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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-12-28

    Teleflex Medical Recalls Flexi Nozzle Short Sprayers for Anesthesia Delivery

    Teleflex Medical is recalling Flexi Nozzle Short sprayers because they may deliver a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.

    Product
    FLEXI NOZZLE SHORT 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…
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    0 states
  • HighFDA (Devices)··2016-12-28

    Teleflex Recalls Mucosal Atomization Devices Due to Incomplete Atomization

    Teleflex Medical is recalling Mucosal Atomization Devices because they may produce a straight stream instead of a fully atomized plume of medication.

    Product
    Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For…
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    0 states
  • ModerateFDA (Devices)··2016-12-28

    Teleflex Medical Recalls Flexi Nozzle Long Sprayers for Inadequate Atomization

    Teleflex Medical is recalling Flexi Nozzle Long sprayers because they may produce a straight stream instead of an atomized plume, potentially causing inadequate anesthesia.

    Product
    FLEXI NOZZLE LONG, 10 Boxes of 25 units each 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…
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    0 states