—#37367

Product

Sheridan 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., Temecula, CA 92589-9020, Manufactured in Mexico; sold under the following catalog numbers: a) catalog number (REF) V5-16037: Novaplus Sterile Sher-I-Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr., Novation Corporation, Irving, TX 75062 b) catalog number (REF) 5-16037: Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube for Left Bronchial Intubation, 37 Fr.

FDA product code: CBI — Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K851856
Affected lot / code info: catalog number (REF) V5-16037, lot number 1145385; catalog number (REF) 5-16037, lot numbers 1147855 and 1146242

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'.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Nationwide and internationally to Argentina, Canada, Chile, China, Costa Rica, Hong Kong, Korea, the Netherlands, South Africa and Vietnam.

Timeline

Recall initiated: 2005-02-23
Posted by FDA: 2005-04-06
Terminated: 2006-07-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #37367. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.