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U.S. Department of Health and Human Services

Class 2 Device Recall Sheridan Preformed Cuffed Tracheal Tube

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  Class 2 Device Recall Sheridan Preformed Cuffed Tracheal Tube see related information
Date Initiated by Firm July 06, 2009
Date Posted August 26, 2009
Recall Status1 Terminated 3 on August 24, 2010
Recall Number Z-1890-2009
Recall Event ID 52782
510(K)Number K822082  
Product Classification Tracheal Tube - Product Code BTR
Product Sheridan Preformed Cuffed Tracheal Tube, Nasal 6.5, Catalog Number: 5-22313, Teleflex Medical Ltd, Research Triangle Park, NC 27709

Used for oral or nasal intubation for airway management.
Code Information Lot number 01A0900364
Recalling Firm/
Manufacturer		 Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
For Additional Information Contact Angela Brown
919-544-8000
Manufacturer Reason
for Recall		 The Nasal Preformed Tracheal Tubes were found to have incorrect insertion depth mark printings.
FDA Determined
Cause 2		 Process control
Action Consignees were notified by an Urgent Medical Device Recall letter on/about 07/06/2009. They were instructed to discontinue use of and return any of the recalled product to Teleflex Medical. Distributors were advised to forward the letter to their consignees to retrieve relevant product from those locations. A Recall Acknowledgement Form was attached to be returned to Teleflex Medical. Replacement product or credit will be provided to the consignee.
Quantity in Commerce 1160 total
Distribution Worldwide Distribution -- USA, including states of CA, FL, IL, KY, MA, NC, NM, NJ, OH, PA, RI, TN, TX, UT, VA, WA, and WI and countries of France and 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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