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Recalled Trach Tubes: Leakage & Disconnection

Nicholas Wills4 years ago

Covidien has issued an immediate recall of certain lots of its Shiley adult tracheostomy tubes in response to reports of leakage and/or disconnection between the inner and outer tubing of the medical devices.

About Tracheostomy Tubes

A tracheostomy is a procedure where an opening is created through the neck into the trachea (aka windpipe). For example, you may have seen a hospital patient with a hole in his/her neck on a public service ad for not smoking. This person most likely underwent a tracheostomy due to problems with breathing. A tracheostomy tube, or “trach tube,” is placed through this opening in the neck to provide an airway to and from the lungs.

About the Recall

  • The particular trach tubes being recalled are its “Shiley™ reusable cannulae, cuffed adult tracheostomy tubes, size 8.”
  • The reported problem is volume leakage and/or disconnection between the inner and outer cannulae. Volume leakage and disconnection can impact ventilation.
  • Cannula” is a tube that is inserted into the body for medical purposes, e.g. fluid extraction, medicinal administration etc.

Covidien recommends customers to return all Shiley “8LPC” and “8FEN” tracheostomy tubes from the affected lots. However, if one of the recalled tubes is already in use by a patient, the Covidien recommends that the tube be replaced as soon as clinically appropriate as determined by the patient’s doctor. If the doctor recommends leaving the tubing in place, Covidien strongly encourages the frequency of patient monitoring to be increased. Replacement tubes are expected to be available soon.

Description of the Recalled Tubes
  • Only certain lots of the size 8 adult, reusable tracheostomy tubes are included.
  • The recalled trach tubes were distributed from October 2009 through June 2012.
  • Affected Units’ Product Codes: 8FEN, 8PLC
  • Affected Lots Under Respective Product Codes

    • 8FEN

      • Lots: 0910000342 – 1101001558
      • Lots: 110201893X – 120600700X
    • 8LPC

      • Lots: 0910000346 – 1101001823
      • Lots: 110200327X – 120600351X
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If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or pharmaceuticals, contact Thomas J. Henry immediately. We are available 24/7, nights and weekends.


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