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U.S. Department of Health and Human Services

Class 2 Device Recall RUSCH ENDOBRONCHIAL TUBE SETS

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  Class 2 Device Recall RUSCH ENDOBRONCHIAL TUBE SETS see related information
Date Initiated by Firm November 21, 2014
Date Posted August 18, 2015
Recall Status1 Terminated 3 on August 15, 2017
Recall Number Z-2410-2015
Recall Event ID 71727
510(K)Number K951091  
Product Classification Tube, bronchial (w/wo connector) - Product Code BTS
Product Bronchial One Lumen Tube - Right
Code Information Product Code 115901-000065 Batch Number 13FT06, 13IT05, 13JT08, 13KT12, 14CT11, 14DT03, 14DT24, 14ET04, 14FT04, 14FT20, 14GT10; Product Code 115901-000080 - Batch Number 13GT16, 13KT18, 13LT08, 14CT11, 14DT03, 14DT24, 14GT15, 14HT12, 14HT20, 14JT04, 14JT12, 14JT21 
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 2		 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 and Original Applicant = RUSCH INTL.
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