FDA-Device2019-06-26Class I
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115, 5-10115, 5-10215 5) CF 8.0 mm, Product Codes: 5-10116, 5-10216, V5-10116 6) CF 8.5 mm, Product Codes: 5-10117, 5-10217 Product Usage: Tracheal tube/airway management
Teleflex Medical
Hazard
This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.
Sold states
Worldwide - US Nationwide Distribution
Affected count
1101073 units
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
Hudson RCI Sheridan: 1) CF 6.0 mm, Product Codes: 5-10112, 5-10212 2) CF 6.5 mm, Product Codes: 5-10113, 5-10213 3) CF 7.0 mm, Product Codes: 5-10114, 5-10214 4) CF 7.5 mm, Product Codes: V5-10115, 5-10115, 5-10215 5) CF 8.0 mm, Product Codes: 5-10116, 5-10216, V5-10116 6) CF 8.5 mm, Product Codes: 5-10117, 5-10217 Product Usage: Tracheal tube/airway management
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1760-2019Don't want to check this manually?
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