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.
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 used for airway management where a disconnection could lead to serious harm, but the source text does not report any specific injuries or illnesses, fitting the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
Teleflex Medical is voluntarily recalling 186,592 units of Hudson RCI Sheridan tracheal tubes. The affected products include preformed sizes ranging from 6.0 mm to 8.5 mm, distributed worldwide and nationwide in the US.
The recall is due to reported complaints indicating an increased incidence of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube. These complaints represent less than 0.0025% of all in-scope distributed product.
Healthcare providers and facilities should check their inventory for the specific product codes and lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to Teleflex Medical according to their instructions.
The recalled product
- 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,
- Manufacturer
- Teleflex Medical
- Hazard
- Affected units
- 186,592
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 (9)
- Hudson RCI Sheridan: 1) Preformed 6.0 mm
- Product Codes: a) 5-22212
- Product Codes: a) 5-22313
- Lot Numbers: 73A1700274 73H1700612 73J1700474 d) 5-22113
- Lot Numbers: 73G1700427 73E1800394 3) Preformed 7.0 mm
- Product Codes: a) 5-22214
- Lot Numbers: 73F1700399 73K1800734 4) Preformed 7.5 mm
- Product Codes: a) 5-22215
- Product Codes: a) 5-22216
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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