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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile Sheridan/HVT Cuffed, Murphy Eye,

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  Class 2 Device Recall Sterile Sheridan/HVT Cuffed, Murphy Eye, see related information
Date Initiated by Firm May 05, 2016
Date Posted June 09, 2016
Recall Status1 Terminated 3 on August 25, 2017
Recall Number Z-1938-2016
Recall Event ID 74034
510(K)Number K822082  
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
Product Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated.

A tracheal tube is inserted into a patients mouth or nose for airway management.
Code Information Lot 73F1500606
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information Contact Alice Harper
610-378-0131
Manufacturer Reason
for Recall		 The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.
FDA Determined
Cause 2		 Error in labeling
Action The firm, Teleflex Medical, sent an "Urgent Medical Device Recall Notification" letter dated May 5, 2016 to its accounts/customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue distribution and quarantine product; communicate this recall to any of your customers who have received product; have your customers return to you any affected product with Recall Acknowledgement Form; contact Teleflex Medical Customer Service for more information at 1-866-246-6990; and complete and return Recall Acknowledgment Form via fax to 1-855-419-850, Attn: Customer Service or email to recalls@teleflex.com, even if you and your customers have no affected stock/product. Teleflex will provide you with instructions for the return of product. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 6,390 ea.
Distribution US Distribution to states of: AL, AZ, CO, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NY, NC, OK, PA, RI, TX and UT.
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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