Sheridan Sher-I-Bronch Endobronchial Tube for Right… recallZ-0681-05 · Teleflex Medical · initiated Feb 23, 2005
Terminated All recalls posted in April 2005
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
The distal end of the tube may be printed incorrectly, with catalog numbers V5-16037 and 5-16037 stating 'Bronchial - Right' instead of 'Bronchial - Left', and catalog number 5-16137 stating 'Bronchial - Left' instead of 'Bronchial - Right'.
FDA root cause category: Other
What the company is doing
Customers were notified via Federal Express, Next Business Day Delivery, on February 23, 2005. The accounts were informed of the mislabeling and were instructed to inspect the product lots for any incorrectly printed devices, comparing the writing on the sleeve of the blue bronchial tube with the package label which is correct, and to return all identified affected product to Teleflex Medical, Hudson RCI.
Recall details
- Recall number
- Z-0681-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 23, 2005
- Posted by the FDA
- Apr 6, 2005
- Recalling firm
- Teleflex Medical
- Product code
- CBI
- FDA submissions
- K851856
- Distribution
- Nationwide and internationally to Argentina, Canada, Chile, China, Costa Rica, Hong Kong, Korea, the Netherlands, South Africa and Vietnam.
Product description
Sheridan Sher-I-Bronch Endobronchial Tube for Right Bronchial Intubation; an Rx, sterile, sinlge use endobronchial tube with modified tip for right bronchial intubation, 37 Fr.; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-16137
Code information (models, lots, serial numbers)
catalog number (REF) 5-16137, lot numbers 1148460 and 1147062
Other devices under the same FDA submission
2 devices cleared under K851856 — 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 IPN044861Teleflex Incorporated · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)10 reports
- HUDSON RCI IPN044860Teleflex Incorporated · TUBE, TRACHEAL/BRONCHIAL, DIFFERENTIAL VENTILATION (W/WO CONNECTOR)7 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 31205).
- Z-0680-05 · TerminatedSheridan Sher-I-Bronch Left Endobronchial Tube; an Rx, sterile, sinlge use endobronchial tube with modified tip for left bronchial intubation, 37 Fr.; Hudson Respiratory Care Inc.,…
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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