Smiths Medical Recalls Mislabelled Portex Low Dead Space Connectors
Smiths Medical ASD, Inc. is recalling one lot of Portex Low Dead Space Connectors with Sideport because 3.0mm devices were packaged and labeled as 3.5mm.
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: "One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm."
Plain-English summary
Smiths Medical ASD, Inc. is recalling one lot of Portex Low Dead Space Connectors with Sideport, 3.5mm. The recall involves 100 devices from Lot No. 2553426, Product Reorder No. 10035-05PS. These devices were distributed in North Carolina.
The recall was initiated because one lot of 3.0mm sized connectors was placed in packages labeled as size 3.5mm. This mislabeling could result in the use of an incorrect size connector for the endotracheal tube, potentially affecting the patient's breathing circuit.
Healthcare providers and facilities that have received these devices should stop using them and contact Smiths Medical ASD, Inc. for further instructions. Consumers are not directly affected as these are medical devices used in clinical settings.
The recalled product
- Product
- Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's…
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- Affected units
- 100
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 or Serial No: 2553426
Distribution
Distributed in 1 state:
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