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Class 2 Device Recall RUSCH ENDOBRONCHIAL TUBE SETS |
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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
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Product Classification |
Tube, bronchial (w/wo connector) - Product Code BTS
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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
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For Additional Information Contact |
610-378-0131
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Manufacturer Reason for Recall |
Customer complaints reporting that the cobb connector detached from the main connector prior to use.
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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
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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.
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510(K) Database |
510(K)s with Product Code = BTS and Original Applicant = RUSCH INTL.
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