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U.S. Department of Health and Human Services

Class 1 Device Recall Hudson RCI Sheridan LTS

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  Class 1 Device Recall Hudson RCI Sheridan LTS see related information
Date Initiated by Firm May 24, 2019
Date Posted June 19, 2019
Recall Status1 Terminated 3 on February 15, 2022
Recall Number Z-1759-2019
Recall Event ID 82964
510(K)Number K822082  
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
Product Hudson RCI Sheridan LTS, Product Code 5-11112

Product Usage:
Tracheal tube/airway management
Code Information Lot Numbers: 73K1600369, 73L1600011, 73A1700646, 73C1700238, 73D1700625, 73E1700475, 73F1700387, 73H1700041, 73H1700483, 73J1700292, 73L1700503, 73M1700453, 73A1800671, 73B1800350, 73D1800138, 73F1800174, 73G1800126, 73G1800806, 73J1800308, 73K1800173, 73L1800225, 73K1800172  
Recalling Firm/
Manufacturer		 Teleflex Medical
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
Manufacturer Reason
for Recall		 This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.
FDA Determined
Cause 2		 Process control
Action Teleflex sent an Urgent Medical Device Recall letter dated May 24, 2019 to customers. The letter identified the affected product, problem and actions to be taken. The letter directed customers to discontinue use, quarantine the product, and contact Teleflex for return of the product. Distributors were directed to notify their customers and request the customer return the recalled products to them for consolidation and subsequent return to Teleflex.. For questions contact your local sales representative or Customer Service at 1-866-396-2111
Quantity in Commerce 3483 units
Distribution Worldwide - US Nationwide Distribution
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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