The Recall Desk

FDA (Devices) recall action 83461

Teleflex Medical recalled 8 products on 2019-09-18

The FDA (Devices) publishes a recall like this one as 8 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 8 pages.

Products
8
Announced
2019-09-18
Critical
1
Units
7,163,704

Why these products were recalled

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

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.

1–8 of 8

  • HighFDA (Devices)··2019-09-18

    Teleflex Recalls Sheridan LTS Tracheal Tubes Due to Disconnection Risk

    Teleflex Medical is recalling specific lots of Sheridan LTS tracheal tubes because the 15 mm connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-09-18

    Teleflex Recalls Sheridan/HVT Novaplus Tracheal Tubes Due to Disconnection Risk

    Teleflex Medical is recalling specific lots of Sheridan/HVT Novaplus tracheal tubes because the 15 mm Sheridan connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Tracheal tube/airway management
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-09-18

    Teleflex Recalls Sheridan EZ-ENDO Tracheal Tubes Due to Disconnection Risk

    Teleflex Medical is recalling specific lots of Sheridan EZ-ENDO tracheal tubes because the 15 mm connector may disconnect, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0 mm, REF 5-22518 h) 6.0 mm, REF 5-22512 i) 6.5 mm, REF 5-22513 Product Usage: Tracheal tube/
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-09-18

    Teleflex Recalls Hudson RCI Sheridan Uncuffed Tracheal Tubes

    Teleflex Medical is recalling Hudson RCI Sheridan Uncuffed tracheal tubes because specific lots of the 15 mm connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-10408 f) 4.5 mm, REF 5-10409 g) 5.0 mm, REF 5-10410 h) 5.5 mm, REF 5-10411 i) 6.0 mm, REF 5-10412 j) 6.5 mm, REF 5-10413 k) 7.0
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-09-18

    Teleflex Medical Recalls Hudson RCI Sheridan/HVT Tracheal Tubes

    Teleflex Medical is recalling specific lots of Hudson RCI Sheridan/HVT tracheal tubes because the 15 mm Sheridan connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF 5-10317 i) 9.0 mm, REF 5-10318 j) 10.0 mm, REF 5-10320 Product Usa
    Category
    Distribution
    0 states
  • CriticalFDA (Devices)··2019-09-18

    Teleflex Medical Recalls Sheridan Preformed Tracheal Tubes Due to Disconnection Risk

    Teleflex Medical is recalling specific lots of Hudson RCI Sheridan Preformed tracheal tubes because the 15 mm connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209 e) 5.0 mm, REF 5-22010, REF 5-22110, REF 5-22210 f) 5.5 mm, REF 5-22011,
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-09-18

    Teleflex Medical Recalls Hudson RCI Sheridan/CF Tracheal Tubes

    Teleflex Medical is recalling Hudson RCI Sheridan/CF tracheal tubes because specific lots of the 15 mm Sheridan connector may disconnect from the endotracheal tube, potentially causing insufficient oxygenation.

    Product
    Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-10111 g) 6.0 mm, REF 5-10112, REF 5-10212 h) 6.5 mm, REF 5-10113, REF 5-1021
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2019-09-18

    Teleflex Recalls Sheridan/CF Novaplus Tracheal Tubes Due to Connector Disconnection

    Teleflex Medical is recalling Sheridan/CF Novaplus 7.0 mm tracheal tubes because the Sheridan connector may disconnect from the tube, potentially causing insufficient oxygenation.

    Product
    Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management
    Category
    Distribution
    0 states