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U.S. Department of Health and Human Services

Class 2 Device Recall Sheridan HVT, Cuffed, Uncuffed Tracheal Tube

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  Class 2 Device Recall Sheridan HVT, Cuffed, Uncuffed Tracheal Tube see related information
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  
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
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
For Additional Information Contact Alice Harper
610-378-0131 Ext. 3548
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.
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
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 = BTR and Original Applicant = SHERIDAN CATHETER CORP.
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