CLASS I Device recall · Reported 18 Sep 2019 · FDA Enforcement Report
Hudson RCI Sheridan LTS: a) recalled by Teleflex Medical
Teleflex Medical is recalling Hudson RCI Sheridan LTS: a), distributed nationwide in the US. The recall was initiated on 30 Jul 2019 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2311-2019
- FDA event ID
- 83461
- Recalling firm
- Teleflex Medical, Morrisville, NC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 30 Jul 2019
- FDA classified
- 9 Sep 2019
- Reported
- 18 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Jul 2019 | Recall initiated by company | |
| 9 Sep 2019 | Classified by FDA | +41 days |
| 18 Sep 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
7 other products · FDA event 83461This product is part of a recall event; the main page for the event is Hudson RCI Sheridan Ez-endo: a) recalled by Teleflex Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Hudson RCI Sheridan Ez-endo: a) recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide | |
| CLASS I | Hudson RCI Sheridan/HVT: a) recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide | |
| CLASS I | Hudson RCI Sheridan/CF: a) recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide | |
| CLASS I | Hudson RCI Sheridan Preformed: a) recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide | |
| CLASS I | Hudson RCI Sheridan Uncuffed: a) recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide | |
| CLASS I | Sheridan/HVT Novaplus: a) recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide | |
| CLASS I | Sheridan/CF Novaplus recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
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