—#36882

Product

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)

FDA product code: BTR — Tube, Tracheal (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K822082
Affected lot / code info: Catalog number V5-10316, lot 1152181, expiry 10-2009

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Teleflex Medical
Address: 2345 Waukegan Rd, Suite 120, Bannockburn, Illinois 60015

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2005-01-14
Posted by FDA: 2005-03-10
Terminated: 2005-08-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36882. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.