Teleflex Recalls Pediatric Nasal Cannulas Due to Incorrect Labeling
Teleflex Medical is recalling 1,150 Hudson RCI Pediatric Nasal Cannulas because the box label says 'Pediatric' while the insert says 'Adult'.
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 involves a labeling error that could lead to incorrect device usage, fitting the criteria for moderate severity.
Plain-English summary
Teleflex Medical is recalling 1,150 units of Hudson RCI Pediatric Nasal Cannulas with Non-Flared Prongs. The recall is due to incorrect labeling where the box indicates the device is for pediatric use, but the product insert indicates it is an adult device.
The affected product is identified by Product Code 1101 and Lot numbers 74J1603122, 74K1601506, 74K1602306, and 74L16006. The devices were distributed in California, Connecticut, Florida, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Nevada, Ohio, Pennsylvania, Texas, Virginia, Wisconsin, and West Virginia.
This is a Class II recall. Consumers and healthcare providers should stop using the affected devices and contact Teleflex Medical for instructions on return or replacement.
The recalled product
- Product
- Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
- Manufacturer
- Teleflex Medical
- Category
- Medical Device — Respiratory
- Hazard
- Affected units
- 1,150
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 (4)
- Product Code: 1101
- Lot numbers: 74J1603122
- 74K1601506
- 74K1602306 and 74L16006.
Distribution
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