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Terminated

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

FDA Recall Z-0681-05 · Posted 2005-04-06

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeCBI
Date Initiated2005-02-23
Date Terminated2006-07-31

Reason for Recall

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'.

Firm Action

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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K851856TRACHEAL/BRONCHIAL DIFFERENTIAL VENTILATION TUBESheridan Catheter Corp. · 1985-05-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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