FDA (Devices) recall action 82964

Teleflex Medical recalled 8 products on 2019-06-26

The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.

Products: 8
Announced: 2019-06-26
Critical: 1
Units: 6,067,497

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–8 of 8

HighFDA (Devices)··2019-06-26
Teleflex Recalls Sheridan Novaplus Endotracheal Tubes Due to Connector Disconnection
Teleflex Medical is voluntarily recalling specific lots of Sheridan Novaplus endotracheal tubes because the 15 mm Sheridan connector may disconnect from the tube.
Product
Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-10317 Product Usage: Tracheal tube/airway management
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0 states
ModerateFDA (Devices)··2019-06-26
Teleflex Recalls Sheridan Tracheal Tubes Due to Connector Disconnection
Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm connector may disconnect from the tube.
Product
Hudson RCI Sheridan: 1) HVT 6.0 mm, Product Code 5-10312 2) HVT 6.5 mm, Product Code 5-10313 3) HVT 7.0 mm, Product Code 5-10314 4) HVT 7.5 mm, Product Code 5-10315 5) HVT 8.0 mm, Product Code 5-10316 6) HVT 8.5 mm, Product Code 5-10317 Product Usage: Tracheal tube/airw
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0 states
CriticalFDA (Devices)··2019-06-26
Teleflex Recalls Sheridan LTS Tracheal Tubes Due to Connector Disconnection
Teleflex Medical is voluntarily recalling specific lots of Sheridan LTS tracheal tubes because the 15 mm connector may disconnect from the tube.
Product
Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
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Distribution
0 states
HighFDA (Devices)··2019-06-26
Teleflex Recalls Hudson RCI Sheridan Endotracheal Tubes Due to Disconnection
Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan EZ-ENDO endotracheal tubes because the 15 mm Sheridan connector may disconnect from the tube.
Product
Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm, Product Code 5-22512 2) EZ-ENDO 6.5 mm, Product Code 5-22513 3) EZ-ENDO 7.0 mm, Product Code 5-22514 4) EZ-ENDO 7.5 mm, Product Code 5-22515 5) EZ-ENDO 8.0 mm, Product Code 5-22516 6) EZ-ENDO 8.5 mm, Product Code 5-22517 Product Us
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0 states
ModerateFDA (Devices)··2019-06-26
Teleflex Recalls Sheridan/CF Novaplus Tracheal Tubes Due to Connector Issues
Teleflex Medical is voluntarily recalling specific lots of Sheridan/CF Novaplus 7.0 mm tracheal tubes because the 15 mm Sheridan connector may disconnect from the tube.
Product
Sheridan/CF Novaplus 7.0 mm, Product Code V5-10114 Product Usage: Tracheal tube/airway management
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Distribution
0 states
HighFDA (Devices)··2019-06-26
Teleflex Medical Recalls Hudson RCI Sheridan Tracheal Tubes Due to Disconnection Risk
Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm connector may disconnect from the endotracheal tube.
Product
Hudson RCI Sheridan: 1) Preformed 6.0 mm, Product Codes: a) 5-22212, b) 5-22312, c) 5-22112, d) 5-22012, 2) Preformed 6.5 mm, Product Codes: a) 5-22313, b) 5-22213, c) 5-22013, d) 5-22113, 3) Preformed 7.0 mm, Product Codes: a) 5-22214, b) 5-22314,
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Distribution
0 states
HighFDA (Devices)··2019-06-26
Teleflex Medical Recalls Hudson RCI Sheridan Tracheal Tubes
Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm Sheridan connector may become disconnected from the endotracheal tube.
Product
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
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Distribution
0 states
HighFDA (Devices)··2019-06-26
Teleflex Recalls Hudson RCI Sheridan Tracheal Tubes Due to Connector Disconnection
Teleflex Medical is voluntarily recalling specific lots of Hudson RCI Sheridan tracheal tubes because the 15 mm connector may disconnect from the endotracheal tube.
Product
Hudson RCI Sheridan: 1) Uncuffed 6.0 mm, Product Code 5-10412 2) Uncuffed 6.5 mm, Product Code 5-10413 3) Uncuffed 7.0 mm, Product Code 5-10414 Product Usage: Tracheal tube/airway management
Category
Distribution
0 states