The Recall Desk
ModerateFDA (Devices)·Z-0703-2020·Announced 2019-12-25

Teleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling

Teleflex Medical is recalling Sheridan Endobronchial Tubes due to incorrectly labeled tracheal and bronchial swivel connectors.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies the issue as incorrect labeling without reporting any illnesses or injuries, fitting the criteria for a moderate severity recall involving labeling errors.

Plain-English summary

Teleflex Medical is recalling 53 units of the HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube (REF 5-16135). The recall was initiated because the tracheal and bronchial swivel connectors on these devices are incorrectly labeled.

The Sheridan Endobronchial Tubes are intended for use in thoracic surgery, bronchospirometry, and the administration of endobronchial anesthesia. They are indicated for main stem bronchus intubation to allow for selective inflation or deflation of either lung.

The affected units were distributed nationwide in the states of Connecticut, Oklahoma, Louisiana, Illinois, Georgia, New York, California, Montana, Michigan, Massachusetts, and Florida. The specific manufacturing lot number is 73G1600257. Healthcare facilities and consumers should stop using the affected devices and contact Teleflex Medical for further instructions.

The recalled product

Product
HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The
Manufacturer
Teleflex Medical
Affected units
53

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)

  • Catalog: 5-16135
  • Manufacturing Lot: 73G1600257

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically: