| Class 2 Device Recall RUSCH ENDOBRONCHIAL TUBE SETS | |
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
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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 |
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 |
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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
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