Z-0997-2009

Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor...

Name: Z-0997-2009 Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor...
Creator: Covidien Limited
Published: 2009-01-14
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2009-01-14 / Terminated

FDA source

Covidien Limited began a recall of Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled... on 2009-01-14. The reason FDA records is "Difficulty inserting an obturator and/or suction catheter into the tracheostomy tube". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0997-2009
Status: Terminated
Initiated: 2009-01-14
Posted: 2009-03-04
Terminated: 2012-05-21
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: Difficulty inserting an obturator and/or suction catheter into the tracheostomy tube.
FDA root cause: Finished device change control
Action: 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.
Quantity in commerce: 8,931 units
Distribution: Nationwide Distribution, including Puerto Rico.
Product codes and lots: Lot Numbers: 0806000266, 0806000858, 0806000859, 0806001328, 0807000555, 0807001444, 0807002502, 0808000387, 0808000431, 0808002285, 0810000288, 0810000289, 0810000864, 0810000865, 0810001201, 0811000228, 0811000522, 0811000523, 0811000546, 0811000547 and 0811001875.

Product code JOH

K945513Class IIMallinckrodt Shiley Neonatal, Pediatric, Long Pediatric Tracheostomy TubeMallinckrodt Medical / cleared 1995-01-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)