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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a mechanical defect that poses a risk of harm (airway disconnection), but the source does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Teleflex Medical is voluntarily recalling 14,357 units of Hudson RCI Sheridan tracheal tubes in uncuffed 6.0 mm, 6.5 mm, and 7.0 mm sizes. The recall covers specific lots distributed nationwide in the United States and worldwide.
The recall is due to reported complaints indicating an increased incidence of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube. The source notes that these complaints represent less than 0.0025% of all in-scope distributed product.
Healthcare facilities and users should identify affected units by checking the product codes and lot numbers listed in the official recall notice. Users should stop using the affected devices and contact Teleflex Medical for instructions on replacement or return.
The recalled product
- 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
- Manufacturer
- Teleflex Medical
- Affected units
- 14,357
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- 1) Uncuffed 6.0 mm
- Product Code 5-10414 Lot Numbers: 73A1700100 73F1700064 73L1800406
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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