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Sheridan Preformed Cuffed Tracheal Tube, Nasal 7.0, Catalog… recallZ-1891-2009 · Teleflex Medical · initiated Jul 6, 2009

Terminated All recalls posted in August 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Teleflex Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1891-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 6, 2009
Posted by the FDA
Aug 26, 2009
Recalling firm
Teleflex Medical
Quantity
1160 total
Product code
BTR
FDA submissions
K822082
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 description

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.

Code information (models, lots, serial numbers)

Lot number 01A0900365

Other devices under the same FDA submission

60 devices cleared under K822082 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 52782).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page