FDA-Device2019-09-18Class I
Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF 5-10317 i) 9.0 mm, REF 5-10318 j) 10.0 mm, REF 5-10320 Product Usage: Tracheal tube/airway management
Teleflex Medical
Hazard
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.
Sold states
US Nationwide Distribution
Affected count
3375808 units
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF 5-10317 i) 9.0 mm, REF 5-10318 j) 10.0 mm, REF 5-10320 Product Usage: Tracheal tube/airway management
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2316-2019Don't want to check this manually?
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