Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only… recallZ-0799-2015 · Teleflex Medical · initiated Nov 12, 2014
Class II Terminated All recalls posted in December 2014
Is my device affected?
- 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.
- 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.
- 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
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0799-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Nov 12, 2014
- Posted by the FDA
- Dec 12, 2014
- Recalling firm
- Teleflex Medical
- Quantity
- 14,000 units
- Product code
- BTR
- FDA submissions
- K822082
- Distribution
- Worldwide Distribution -- U.S., Belgium, Canada, and Japan.
Product description
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.
Code information (models, lots, serial numbers)
Product Code: 5-10116, Lot number: 01A1400211
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.
- HUDSON RCI IPN044731Teleflex Incorporated · Tube, tracheal (w/wo connector)42 reports
- HUDSON RCI IPN048896Teleflex Incorporated · Tube, tracheal (w/wo connector)2 deaths32 reports
- HUDSON RCI IPN044767Teleflex Incorporated · Tube, tracheal (w/wo connector)31 reports
- HUDSON RCI IPN048895Teleflex Incorporated · Tube, tracheal (w/wo connector)1 death27 reports
- HUDSON RCI IPN046756Teleflex Incorporated · Tube, tracheal (w/wo connector)25 reports
- HUDSON RCI IPN048873Teleflex Incorporated · Tube, tracheal (w/wo connector)25 reports
- HUDSON RCI IPN044732Teleflex Incorporated · Tube, tracheal (w/wo connector)21 reports
- HUDSON RCI IPN044730Teleflex Incorporated · Tube, tracheal (w/wo connector)20 reports
- HUDSON RCI IPN048874Teleflex Incorporated · Tube, tracheal (w/wo connector)20 reports
- HUDSON RCI IPN046759Teleflex Incorporated · Tube, tracheal (w/wo connector)19 reports
- HUDSON RCI IPN044768Teleflex Incorporated · Tube, tracheal (w/wo connector)17 reports
- HUDSON RCI IPN048897Teleflex Incorporated · Tube, tracheal (w/wo connector)15 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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