Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube recallZ-0582-05 · Teleflex Medical · initiated Jan 14, 2005
Terminated All recalls posted in March 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
Some of the primary labels have the internal diameter (ID) and outer diameter (OD) numbers reversed, i.e. ID 10.9 mm and OD 8.0 mm instead of the actual ID 8.0 and OD 10.9 mm, mislabeling the size of the tracheal tube.
FDA root cause category: Other
What the company is doing
The direct accounts were notified of the mislabeling by letter dated 1/14/05, sent via Federal Express, Next Business Day Delivery on the same date. The accounts were requested to return their inventories of the affected lot to Teleflex Medical/Hudson RCI, and to subrecall the lot from their customers.
Recall details
- Recall number
- Z-0582-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 14, 2005
- Posted by the FDA
- Mar 10, 2005
- Recalling firm
- Teleflex Medical
- Quantity
- 8,990 units
- Product code
- BTR
- FDA submissions
- K822082
- Distribution
- Nationwide
Product description
Novaplus Sheridan/HVT Cuffed, Murphy Eye Tracheal Tube; an Rx, ETO sterilized, single use device inserted into the patient's trachea via the mouth to maintain an open airway; Hudson RCI, Temecula, CA 92589-9020, Manufactured in Mexico, Catalog number (REF) V5-10316 (8.0 mm)
Code information (models, lots, serial numbers)
Catalog number V5-10316, lot 1152181, expiry 10-2009
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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