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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 July 30, 2019
Date Posted September 09, 2019
Recall Status1 Terminated 3 on February 15, 2022
Recall Number Z-2311-2019
Recall Event ID 83461
510(K)Number K822082  
Product Classification Tube, tracheal (w/wo connector): - Product Code BTR
Product Hudson RCI Sheridan LTS:
a) 4.0 mm, REF 5-11108
b) 5.0 mm, REF 5-11110
c) 6.0 mm, REF 5-11112

Product Usage:
Tracheal tube/airway management
Code Information a) REF 5-11108 Batch numbers: 73L1600010 73A1700644 73C1700236 73D1700438 73E1700473 73F1700385 73K1700066 73L1700501 73B1800123 73D1800137 73F1800172 73G1800124 73G1800925 73H1800731  b) REF 5-11110 Batch numbers: 73K1600368 73K1600727 73A1700645 73B1700410 73C1700237 73D1700624 73E1700474 73F1700386 73H1700040 73H1700482 73H1700599 73J1700291 73K1700067 73L1700502 73M1700452 73B1800124 73D1800313 73F1800173 73G1800125 73K1800170 73L1800224  c) REF 5-11112 Batch 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		 Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.
FDA Determined
Cause 2		 Process control
Action Teleflex sent an Urgent Medical Device Recall Notification letter dated July 30, 2019 to affected customers. The letter explains the problem and requests the consignee discontinue use and quarantine of any of the recalled products then to notify Teleflex. The firm is requesting the return of the affected products. For questions, contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in Commerce 7963 units
Distribution 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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