Centurion Recalls Sheridan Endotracheal Tubes for Connector Disconnection
Centurion Medical Products is recalling 80 Sheridan Endotracheal Tubes due to an increased incidence of the connector becoming disconnected 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Centurion is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tracheal Tubes due to increased incidence of Sheridan connector becoming disconnected from Endotracheal Tube."
Plain-English summary
Centurion Medical Products Corporation is conducting a sub-recall for Teleflex Sheridan branded Endotracheal Tubes. The recall involves 80 kits, specifically the Sheridan Endotracheal Tube contained inside Centurion kit code TC7855. The affected products are identified by Lot 2018110290.
The recall is being conducted due to an increased incidence of the Sheridan connector becoming disconnected from the Endotracheal Tube. This defect poses a risk of the device failing to maintain airway patency during use.
The affected products were distributed to one account in Arkansas. Centurion Medical Products Corporation is the recalling firm. Consumers and healthcare providers should stop using the affected products and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Sheridan Endotracheal Tube contained inside Centurion kit code TC7855.
- Manufacturer
- Centurion Medical Products Corporation
- Affected units
- 80
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 (1)
- Lot 2018110290
Distribution
Distributed in 1 state:
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