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Sheridan Preformed Cuffed Oral Tracheal Tube, 5.0 mm recallZ-0127-2007 · Teleflex Medical · initiated Sep 27, 2006

Terminated All recalls posted in November 2006

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

Biological indicator failed. Investigation eliminated all equipment and product related factors.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0127-2007
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Sep 27, 2006
Posted by the FDA
Nov 2, 2006
Recalling firm
Teleflex Medical
Quantity
830 units
Product code
BTR
FDA submissions
K822082
Distribution
Nationwide and Argentina, Canada, Chile, Japan, Malaysia, the Netherlands and New Zealand

Product description

Sheridan Preformed Cuffed Oral Tracheal Tube, 5.0 mm; a Rx, sterile, single use tracheal tube; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-22210

Code information (models, lots, serial numbers)

catalog number (REF) 5-22210, lot number 1189023

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 36426).

Sources and updates

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