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Shiley Cuffed Pediatric Tracheostomy Tube, 4.5 PDC… recallZ-1493-2010 · Nellcor Puritan Bennett Inc. (dba Covidien Ltd) · initiated Apr 13, 2010

Terminated All recalls posted in May 2010

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Nellcor Puritan Bennett Inc. (dba Covidien Ltd) or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.

FDA root cause category: Process design

What the company is doing

Covidien issued an "Urgent Medical Device Recall" notification dated April 13, 2010. Consignees were alerted to the affected device. If an affected product is already in use, the firm recommends that the tube be replaced as soon as the patient's physician determines it is clinically appropriate. All affected product is to be returned to the firm. For further Information, contact Covidien at 1-800-635-5267.

Recall details

Recall number
Z-1493-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 13, 2010
Posted by the FDA
May 6, 2010
Recalling firm
Nellcor Puritan Bennett Inc. (dba Covidien Ltd)
Quantity
4,435 units
Product code
JOH
FDA submissions
K955680
Distribution
Worldwide Distribution -- United States (including Guam and Puerto Rico), Australia, Belgium, Brazil, Canada, Chile, Colombia, Honduras, Japan, Mexico, Panama, Singapore and Uruguay.

Product description

Shiley Cuffed Pediatric Tracheostomy Tube, 4.5 PDC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions.

Code information (models, lots, serial numbers)

Lot Numbers: 0903000861 through 0908000693

Other devices under the same FDA submission

8 devices cleared under K955680 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 55354).

Sources and updates

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