The Recall Desk

FDA (Devices) recall action 65093

Covidien LP recalled 6 products on 2013-06-12

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
2013-06-12
Critical
0
Units
218,221

Why these products were recalled

Seals may disengage from the cannula which may result in a component inadvertently disengaging into the patients cavity

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.

1–6 of 6

  • SevereFDA (Devices)··2013-06-12

    FDA Recalls Versaport Bladeless Optical Trocars Due to Seal Disengagement Risk

    The FDA is recalling 23,050 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially causing components to enter the patient's cavity.

    Product
    Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Short Product Code: ONB5SHF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of en
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2013-06-12

    FDA Recalls Versaport Bladeless Optical Trocars Due to Seal Disengagement Risk

    The FDA is recalling 5,364 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially allowing components to enter the patient's cavity.

    Product
    Versaport Bladeless Optical Trocar With (2) Fixation Cannulae - 5mm Product Code: ONB5STF2C The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of e
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2013-06-12

    FDA Recalls Versaport Bladeless Optical Trocars Due to Seal Disengagement Risk

    The FDA is recalling 2,716 units of Versaport Bladeless Optical Trocars because seals may disengage, potentially causing components to enter the patient's cavity.

    Product
    Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Long Product Code: ONB5LGF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entr
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-06-12

    FDA Recalls Versaport Bladeless Optical Fixation Cannulas Due to Seal Disengagement

    The FDA is recalling Versaport Bladeless Optical Fixation Cannulas because seals may disengage, potentially causing components to enter the patient's cavity.

    Product
    Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2013-06-12

    Recall of Versaport Bladeless Optical Trocar Due to Seal Disengagement

    FDA Class II recall of 126,925 Versaport trocars because seals may disengage, risking component entry into the patient's cavity.

    Product
    Versaport Bladeless Optical Trocar With Fixation Cannula - 5mm Product Code: ONB5STF The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2013-06-12

    FDA Recalls Versaport Bladeless Optical Fixation Cannulas Due to Seal Disengagement

    The FDA is recalling Versaport Bladeless Optical Fixation Cannulas because seals may disengage, potentially causing components to enter the patient's cavity.

    Product
    Versaport Bladeless Optical Fixation Cannula - 5mm Product Code: ONBFCA5ST The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
    Category
    Distribution
    0 states