—#48634

Product

Sheridan Sher-I-Bronch Endobronchial Tube, Left-Sided, 37 Fr, 26 mm tracheal cuff, 19 mm bronchial cuff; a Rx, sterile, single use endobronchial tube with modified tip for left bronchial intubation; Hudson Respiratory Care Inc., Temecula, CA 92589-9020, Manufactured in Mexico; catalog number (REF) 5-16037

FDA product code: BTS — Tube, Bronchial (W/Wo Connector)
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K961977
Affected lot / code info: catalog (REF) number 5-16037, lot number 1188199

Why it was recalled

Biological indicator failed. Investigation eliminated all equipment and product related factors.

Root cause (FDA determination)

Other

Action the firm took

Teleflex Medical sent Urgent Medical Device Recall letters dated 9/27/06 via UPS overnight to the direct accounts, informing them that the product did not pass validated sterility test requirements, and requesting that they cease use of the affected units and return them to Teleflex Medical for replacement. If the accounts further distributed the product, they were requested to conduct a sub-recall of the affected units from their customers. The accounts were instructed to complete and return by fax the enclosed Acknowledgement & Stock Status Form, indicating the number of units being returned for replacement. Any questions were directed to Linda Todd at 1-800-334-9751, ext. 4951.

Recalling firm

Firm: Teleflex Medical
Address: 2345 Waukegan Rd, Ste 120, Bannockburn, Illinois 60015-1580

Distribution

Distribution pattern: Nationwide and Argentina, Canada, Chile, Japan, Malaysia, the Netherlands and New Zealand

Timeline

Recall initiated: 2006-09-27
Posted by FDA: 2006-11-02
Terminated: 2009-08-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48634. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.