Class 1 Device Recall Hudson RCI Sheridan LTS:

• Date Initiated by Firm: July 30, 2019
• Date Posted: September 09, 2019
• Recall Status: Terminated on February 15, 2022
• Recall Number: Z-2313-2019
• Recall Event ID: 83461
• 510(K)Number: K822082
• Product Classification: Tube, tracheal (w/wo connector) - Product Code BTR
• Product: Hudson RCI Sheridan EZ-ENDO:; a) 5.0 mm, REF 5-22510; b) 5.5 mm, REF 5-22511; c) 7.0 mm, REF 5-22514; d) 7.5 mm, REF 5-22515; e) 8.0 mm, REF 5-22516; f) 8.5 mm, REF 5-22517; g) 9.0 mm, REF 5-22518; h) 6.0 mm, REF 5-22512; i) 6.5 mm, REF 5-22513; ; ; Product Usage:; Tracheal tube/airway management
• Code Information: a) REF 5-22510 Batch numbers: 73B1700556 73D1700650 73H1700346 73H1800449 b) REF 5-22511 Batch numbers: 73C1700261 73K1700609 73C1800370 c) REF 5-22514 Batch numbers: 73A1700118 73C1700569 73E1700722 73F1700175 73F1700405 73G1700433 73H1700349 73H1700494 73H1700711 73J1700143 73K1700081 73K1700610 73L1700181 73M1700273 73D1800653 73F1800562 73F1800720 73H1800450 73J1800531 73K1800328 73K1800786 d) REF 5-22515 Batch numbers: 73B1700316 73C1700262 73C1700418 73E1700723 73E1700104 73F1700176 73F1700406 73G1700434 73H1700350 73J1700302 73J1700497 73K1700747 73M1700274 73A1800068 73A1800683 73B1800502 73C1800201 73D1800154 73E1800402 73F1800565 73G1800591 73H1800451 73H1800686 73J1800113 73K1800736 e) REF 5-22516 Batch numbers: 73K1600594 73A1700282 73B1700158 73B1700317 73C1700570 73F1700036 73F1700177 73F1700407 73G1700614 73H1700495 73J1700487 73K1700082 73A1800684 73B1800503 73C1800371 73E1800577 73G1800232 73J1800532 73K1800327 f) REF 5-22517 Batch numbers: 73J1600767 73C1800202 g) REF 5-22518 Batch numbers: 73K1600595 73E1800459 73M1800288 h) REF 5-22512 Batch numbers: 73K1600152 73M1600163 73A1700280 73C1700567 73E1700496 73F1700403 73H1700347 73M1700272 73E1800401 73E1800575 73F1800354 i) REF 5-22513 Batch numbers: 73J1600766 73B1700155 73C1700568 73F1700404 73G1700432 73H1700348 73E1800576 73F1800355
• 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: 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: 57181units
• 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.