Z-0128-2007

Sheridan Preformed Cuffed Nasal Tracheal Tube, 7.5 mm; a Rx, sterile, single use tracheal tube; Hudson...

Name: Z-0128-2007 Sheridan Preformed Cuffed Nasal Tracheal Tube, 7.5 mm; a Rx, sterile, single use tracheal tube; Hudson...
Creator: Teleflex Medical
Published: 2006-09-27
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2006-09-27 / Terminated

FDA source

Teleflex Medical began a recall of Sheridan Preformed Cuffed Nasal Tracheal Tube, 7.5 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020... on 2006-09-27. The reason FDA records is "Biological indicator failed. Investigation eliminated all equipment and product related factors". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0128-2007
Status: Terminated
Initiated: 2006-09-27
Posted: 2006-11-02
Terminated: 2009-08-12
Recalling firm: Teleflex Medical
Product: Sheridan Preformed Cuffed Nasal Tracheal Tube, 7.5 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-22315
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: Biological indicator failed. Investigation eliminated all equipment and product related factors.
FDA root cause: Other
Action: Teleflex Medical sent Urgent Medical Device Recall letters dated 9/27/06 via UPS overnight to the direct accounts, informing them that the product did not pass validated sterility test requirements, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.
Quantity in commerce: 990 units
Distribution: Nationwide and Argentina, Canada, Chile, Japan, Malaysia, the Netherlands and New Zealand
Product codes and lots: catalog number (REF) 5-22315, lot number 1189026

Product code BTR

K822082Class IISheridan/hvt,cf, UncuffedSheridan Catheter Corp. / cleared 1982-08-10

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)