Reported Sep 18, 2019 · Terminated
Hudson RCI Sheridan/HVT
Teleflex Medical
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teleflex Medical · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
Hudson RCI Sheridan/HVT
10 of 10 products
| Model / number | Product as published |
|---|---|
5-10310 | 5.0 mm |
5-10311 | 5.5 mm |
5-10312 | 6.0 mm |
5-10313 | 6.5 mm |
5-10314 | 7.0 mm |
5-10315 | 7.5 mm |
5-10316 | 8.0 mm |
5-10317 | 8.5 mm |
5-10318 | 9.0 mm |
5-10320 | 10.0 mm, Product Usage: Tracheal tube/airway management |
- Amount recalled
- 3375808 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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