Z-1891-2009

Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314, Teleflex Medical Ltd, Research...

Name: Z-1891-2009 Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314, Teleflex Medical Ltd, Research...
Creator: Teleflex Medical
Published: 2009-07-06
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2009-07-06 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314, Teleflex Medical Ltd, Research Triangle Park, NC 27709 Used for oral or nasal... on 2009-07-06. The reason FDA records is "The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings". 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-1891-2009
Status: Terminated
Initiated: 2009-07-06
Posted: 2009-08-26
Terminated: 2010-08-24
Recalling firm: Teleflex Medical
Product: Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog Number: 5-22314, Teleflex Medical Ltd, Research Triangle Park, NC 27709 Used for oral or nasal intubation for airway management.
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified by an Urgent Medical Device Recall letter on/about 07/06/2009. They were instructed to discontinue use of and return any of the recalled product to Teleflex Medical. Distributors were advised to forward the letter to their consignees to retrieve relevant product from those locations. A Recall Acknowledgement Form was attached to be returned to Teleflex Medical. Replacement product or credit will be provided to the consignee.
Quantity in commerce: 1160 total
Distribution: Worldwide Distribution -- USA, including states of CA, FL, IL, KY, MA, NC, NM, NJ, OH, PA, RI, TN, TX, UT, VA, WA, and WI and countries of France and Japan.
Product codes and lots: Lot number 01A0900365

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