Teleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
Teleflex Medical is recalling Sheridan Endobronchial Tubes due to incorrectly labeled tracheal and bronchial swivel connectors.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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
- Hazard
- 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
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Similar recalls
- CriticalTeleflex Medical Recalls Sheridan Sher-I-BRONCH Endobronchial Tubes
FDA (Devices) · 2015-08-26
- SevereTeleflex Recalls Sheridan Sher-I-BRONCH Endobronchial Tubes Due to Connector Cracking
FDA (Devices) · 2015-08-26
- SevereTeleflex Medical Recalls Sheridan Double Swivel Connectors Due to Cracking Risk
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- HighTeleflex Recalls Sheridan Cuffed Tracheal Tubes Due to Labeling Inconsistency
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- ModerateTeleflex Recalls Preformed Tracheal Tubes Due to Incorrect Labeling
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- SevereTeleflex Sheridan SHER-I Bronch Accessory Pack Recalled for Connector Defect
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