The Recall Desk

FDA (Devices) recall action 71360

Teleflex Medical recalled 4 products on 2015-08-26

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2015-08-26
Critical
1
Units
752,780

Why these products were recalled

The double swivel connector may crack or separate on the endobronchial tube.

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.

1–4 of 4

  • HighFDA (Devices)··2015-08-26

    Teleflex Recalls Sheridan Sher-I-BRONCH Endobronchial Tubes Due to Connector Cracking

    Teleflex Medical is recalling Sheridan Sher-I-BRONCH endobronchial tubes because the double swivel connector may crack or separate.

    Product
    HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring b
    Category
    Distribution
    0 states
  • CriticalFDA (Devices)··2015-08-26

    Teleflex Medical Recalls Sheridan Sher-I-BRONCH Endobronchial Tubes

    Teleflex Medical is recalling Sheridan Sher-I-BRONCH endobronchial tubes because the double swivel connector may crack or separate.

    Product
    HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring br
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2015-08-26

    Teleflex Sheridan SHER-I Bronch Accessory Pack Recalled for Connector Defect

    Teleflex Medical is recalling Sheridan SHER-I Bronch Accessory Packs because the double swivel connector may crack or separate on the endobronchial tube.

    Product
    HUDSON RCI, Sheridan SHER-I BRONCH Accessory Pack, Rx Only, Sterile. Used to aspirate liquids or semisolids from a patient's upper airway.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-08-26

    Teleflex Medical Recalls Sheridan Double Swivel Connectors Due to Cracking Risk

    Teleflex Medical is recalling Sheridan double swivel connectors because they may crack or separate on endobronchial tubes.

    Product
    HUDSON RCI, Sheridan, SHER-I-SWIV and SHER-I-SWIV/FO Double Swivel, Rx Only, Sterile. Used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.
    Category
    Distribution
    0 states