Z-0721-05

Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070...

Name: Z-0721-05 Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070...
Creator: Nellcor Puritan Bennett
Published: 2004-12-09
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2004-12-09 / Terminated

FDA source

Nellcor Puritan Bennett began a recall of Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; 358080, Size 8, FlexTra... on 2004-12-09. The reason FDA records is "Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0721-05
Status: Terminated
Initiated: 2004-12-09
Posted: 2005-04-22
Terminated: 2006-01-18
Recalling firm: Medtronic, Inc.
Product: Shiley FlexTra brand Flexible Dual-Cannula Tracheostomy Tube, Models: 358060, Size 6, FlexTra Cuffed; 358070, Size 7, FlexTra Cuffed; 358080, Size 8, FlexTra Cuffed; 358090, Size 9, FlexTra Cuffed; 358100, Size 10, FlexTra Cuffed; 359060, Size 6, FlexTra Uncuffed; 359070, Size 7, FlexTra Uncuffed; 359080, Size 8, FlexTra Uncuffed; 359090, Size 9, FlexTra Uncuffed; 359100, Size 10, FlexTra Uncuffed, Tyco Healthcare/Nellcor is currently responsible for Research and Development for this product. Tyco Healthcare/MMJ S.A. De C.V., Cuidad Juarez, Mexico manufactures the FlexTra Tracheostomy Tube. The product is sterilized at Sterigenics, located at Santa Teresa, New Mexico.
Product code: JDH Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
Reason for recall: Outer cannula has the potential to separate from the head/flange assembly, leading to ineffective ventilation, which could result in serious injury.
FDA root cause: Other
Action: On 12/3/04, the firm issued letters to all its international consignees, informing them of the affected product and providing instructions on the recall.
Quantity in commerce: 323 units shipped to US Field Personnel or Healthcare facilities.
Distribution: The firm has indicated that product was released for distribution to 7 consignees in US and to 17 foreign countries via international distribution centers. The firm has indicated that a very limited number of the product was distributed in the US to selected facilities that were participating in customer preference testing, after the device had received 510(k) clearance and all remaining stock was collected and returned to the company. Tyco Healthcare/Nellcor shipped Tyco Healthcare affiliate offices outside of the US. Foreign distribution include: Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Holland, Italy, Norway, Poland, Singapore, Spain, Sweden, Switzerland and United Kingdom.
Product codes and lots: All codes are affected.

Product code JDH

K030787Class IIShiley Flextra Tracheostomy TubeNellcor Puritan Bennett, Inc. / cleared 2003-11-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)