Z-0799-2015Class II

Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708...

Name: Z-0799-2015 Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708...
Creator: Teleflex Medical
Published: 2014-11-12
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-11-12 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are... on 2014-11-12. FDA classified it as Class II and gives the reason as "Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0799-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-12
Posted: 2014-12-12
Terminated: 2017-10-13
Recalling firm: Teleflex Medical
Product: Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management.
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified by an Urgent Medical Device Recall Notification letter on 11/12/2014. The letter identified the affected product, as well as, the reason for the recall. Customers are instructed to immediately discontinue use of and quarantine any affected product. They are also instructed to complete and fax or e-mail the enclosed Recall Acknowledgement Form regardless of whether they have affected product in stock or not. Upon receipt of the form, a customer service representative will contact customers to provide an RGA number, as well as, instructions for the return of the product. A local sales representative or customer service should be contacted with questions at 1-866-246-6990.
Quantity in commerce: 14,000 units
Distribution: Worldwide Distribution -- U.S., Belgium, Canada, and Japan.
Product codes and lots: Product Code: 5-10116, Lot number: 01A1400211

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0799-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0799-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-12

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)