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Class 2 Device Recall Sheridan HVT, Cuffed, Uncuffed Tracheal Tube |
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Date Initiated by Firm |
October 18, 2016 |
Date Posted |
February 09, 2017 |
Recall Status1 |
Terminated 3 on August 25, 2017 |
Recall Number |
Z-1177-2017 |
Recall Event ID |
76133 |
510(K)Number |
K822082
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Product Classification |
Tube, tracheal (w/wo connector) - Product Code BTR
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Product |
Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserted into a patients mouth or nose for airway management |
Code Information |
Lots 73A1500461 & 73D1400082 |
Recalling Firm/ Manufacturer |
Teleflex Medical 2917 Weck Dr Research Triangle Park NC 27709-0186
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For Additional Information Contact |
Alice Harper 610-378-0131 Ext. 3548
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Manufacturer Reason for Recall |
Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube.
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FDA Determined Cause 2 |
Other |
Action |
Teleflex sent an Medical Device Recall Notification letter dated October 18, 2016, to all affected customers. Customers were advised to immediately discontinue use and to quarantine product. The letter to distributors requested a sub-recall. Both letters included an acknowledgement form to be returned. Customers with questions were instructed to contact their local representative or Customer Service at 1-800-246-6990. |
Quantity in Commerce |
25,274 units |
Distribution |
Worldwide Distribution - US including AL, AZ, ARK, CA, CO, CT, FL, GA. HI, KS, KY, IL, IN, IA, LA, MD, MA, MI, MN, MS, MO, MT, NE, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV and Internationally to Canada, Chile, & Japan |
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 = BTR and Original Applicant = SHERIDAN CATHETER CORP.
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