The Recall Desk

FDA (Devices) recall action 67819

Teleflex Medical recalled 6 products on 2014-04-09

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2014-04-09
Critical
0
Units
333,126

Why these products were recalled

Complaints of leakage of insufflation gas through the device.

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.

States named across these recalls

1–6 of 6

  • HighFDA (Devices)··2014-04-09

    Teleflex Recalls Weck Vista Optical Bladeless Laparoscopic Access Ports

    Teleflex Medical is recalling 55,521 Weck Vista Optical Bladeless Laparoscopic Access Ports due to complaints of insufflation gas leakage.

    Product
    5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405912R. An endoscope and accessories is a device used to provide access, illumination, and allow observation or…
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2014-04-09

    Teleflex Medical Recalls Weck Vista Cannulas Due to Gas Leakage

    Teleflex Medical is recalling 55,521 units of 10mm and 12mm Weck Vista Cannulas because they may leak insufflation gas.

    Product
    10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2014-04-09

    Teleflex Medical Recalls Weck Vista Universal Cannulas Due to Gas Leakage

    Teleflex Medical is recalling 55,521 Weck Vista Universal Cannulas because they may leak insufflation gas during use.

    Product
    5/10 mm Weck Vista Universal Cannula, Catalog No. 405910RC; 5/10/12 mm Weck Vista Universal Cannula, Catalog No. 405912RC. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and…
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2014-04-09

    Teleflex Medical Recalls Weck Vista Universal Cone Open Access Devices

    Teleflex Medical is recalling 55,521 Weck Vista Universal Cone Open Access devices due to complaints of insufflation gas leakage.

    Product
    5/10/12 mm x 100mm Weck Vista Universal Cone Open Access, Catalog No. 405933. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2014-04-09

    Teleflex Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage

    Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports worldwide because they may leak insufflation gas during use.

    Product
    Weck Vista Universal Laparoscopic Port, Size 5/10mm x 100mm, Catalog No. 405910, Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 100mm, Catalog No. 405912; Weck Vista Universal Laparoscopic Port, Size 5/10/12mm x 125mm, Catalog No. 40591213. An endoscope and…
    Category
    Distribution
    34 states
  • HighFDA (Devices)··2014-04-09

    Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports

    Teleflex Medical is recalling 55,521 units of Weck Vista Universal Balloon Open Access Ports due to complaints of leakage of insufflation gas through the device.

    Product
    5/10 Weck Vista Universal Balloon Open Access Port - Standard Length (70mm), Catalog No. 410944, 5/10 Weck Vista Universal Balloon Open Access Port - Long Length (100mm), Catalog No. 410944L; 5/10 Weck Vista Universal Balloon Open Access Port - Short Length (53mm), Catalog No.…
    Category
    Distribution
    34 states