The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1759-2019·Announced 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.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source metadata explicitly identifies this as an FDA Class I recall. Per the rubric, FDA Class I recalls are classified as Critical (Score 5).

Plain-English summary

Teleflex Medical is voluntarily recalling 3,483 units of the Hudson RCI Sheridan LTS tracheal tube (Product Code 5-11112). The recall covers specific lots distributed worldwide and across the United States.

The recall is being conducted 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.

This is an FDA Class I recall. The product is used for tracheal tube and airway management. Users should stop using the affected lots and contact Teleflex Medical for further instructions.

The recalled product

Product
Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
Manufacturer
Teleflex Medical
Category
Medical Device — Airway Management
Hazard
Affected units
3,483

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 (20)

  • Lot Numbers: 73K1600369
  • 73L1600011
  • 73A1700646
  • 73C1700238
  • 73D1700625
  • 73E1700475
  • 73F1700387
  • 73H1700041
  • 73H1700483
  • 73J1700292
  • 73L1700503
  • 73M1700453
  • 73A1800671
  • 73B1800350
  • 73D1800138
  • 73F1800174
  • 73G1800126
  • 73G1800806
  • 73J1800308
  • 73K1800173

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.

See all 8 products in this recall →

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