B. Braun Introcan Safety IV Catheters Recalled for Missing 510(k) Clearance
Janus Trade Group is recalling B. Braun Introcan Safety IV Catheters distributed in the US without required FDA 510(k) clearance.
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, but the source text explicitly states the issue is the lack of 510(k) clearance and does not report any illnesses or injuries, fitting the criteria for a moderate severity regulatory compliance issue.
Plain-English summary
Janus Trade Group is recalling B. Braun Introcan Safety IV Catheters that were distributed within the United States without the required FDA 510(k) clearance. The recall involves 1,365 cases (200 units per case) of the product, which was distributed to distributors located in California, Florida, Illinois, Kansas, New Jersey, New York, and Tennessee.
The recall is being conducted because the devices were distributed without the necessary regulatory clearance. The source text does not report any specific illnesses, injuries, or adverse events associated with the use of these catheters. The recall is classified as Class II by the FDA.
Healthcare facilities and distributors should stop using the affected product and contact Janus Trade Group for instructions on return or disposal. Consumers should not use these devices if they have them in their possession.
The recalled product
- Product
- B. Braun Introcan Safety IV Catheters, Product codes REF 4252500-01 4252519-01 4252535-01 4252560-01 4252586-01 4251890-01 4252535-01 4252586-01 4251644-01
- Manufacturer
- Janus Trade Group
- Category
- Medical Device — IV Catheters
Distribution
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