Class 2 Device Recall RUSCH ENDOBRONCHIAL TUBE SETS

• Date Initiated by Firm: November 21, 2014
• Date Posted: August 18, 2015
• Recall Status: Terminated on August 15, 2017
• Recall Number: Z-2415-2015
• Recall Event ID: 71727
• 510(K)Number: K951091
• Product Classification: Tube, bronchial (w/wo connector) - Product Code BTS
• Product: Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile
• Code Information: Product Code 116164-000390  Batch Number 14BT21
• Recalling Firm/ Manufacturer: Teleflex, Inc.; 550 E Swedesford Rd Ste 400; Wayne PA 19087-1601
• For Additional Information Contact: 610-378-0131
• Manufacturer Reason for Recall: Customer complaints reporting that the cobb connector detached from the main connector prior to use.
• FDA Determined Cause: Other
• Action: Recall letters were sent on 11/21/2014 to consignees requesting them to discontinue use and quarantine the products. The letter includes a reply form to be returned. The letter to the distributors requested a sub-recall, and included a recall letter to be sent to their accounts.
• Distribution: AL, AK, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV. WI, DC, Puerto Rico, Canada, Bolivia, Ecuador, Hong Kong, Malaysia, Philippines, Taiwan, Trinidad & Tobago
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = BTS