Skip to content

Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0… recallZ-0997-2009 · Covidien Limited · initiated Jan 14, 2009

Terminated All recalls posted in March 2009

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 Covidien Limited 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

Difficulty inserting an obturator and/or suction catheter into the tracheostomy tube.

FDA root cause category: Finished device change control

What the company is doing

Consignees were sent an "Urgent Device Alert" letter dated 01/14/2009, by mail via Federal Express overnight delivery and instructed to evaluate any of the affected lot numbers of tracheostomy tubes prior to placement into a patient's stoma. If either the obturator or the desired sterile suction catheter does not fit properly into the tube, the tube must not be inserted into the patient. Further instructions are available at Nellcor Technical Services by calling 1-800-635-5267, option 3, then option 1. New product was expected by mid February, 2009, to address the issue.

Recall details

Recall number
Z-0997-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 14, 2009
Posted by the FDA
Mar 4, 2009
Recalling firm
Covidien Limited
Quantity
8,931 units
Product code
JOH
FDA submissions
K945513
Distribution
Nationwide Distribution, including Puerto Rico.

Product description

Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. The product is provided as one each shipped in an inner carton to end customers. The intended use of the device is to bypass upper airway obstructions, provide long term ventilation, and support and/or manage tracheal/bronchial secretions.

Code information (models, lots, serial numbers)

Lot Numbers: 0806000266, 0806000858, 0806000859, 0806001328, 0807000555, 0807001444, 0807002502, 0808000387, 0808000431, 0808002285, 0810000288, 0810000289, 0810000864, 0810000865, 0810001201, 0811000228, 0811000522, 0811000523, 0811000546, 0811000547 and 0811001875.

Other devices under the same FDA submission

18 devices cleared under K945513 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page