Radiometer safeCLINITUBES Blood Samplers Recalled for Insufficient Aspiration
Radiometer Medical ApS is recalling safeCLINITUBES Blood Samplers because they may have insufficient aspiration capabilities, resulting in lost samples.
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. The hazard involves the loss of samples rather than direct physical injury or death, fitting the criteria for a moderate severity recall where the risk is operational rather than immediate physical harm.
Plain-English summary
Radiometer Medical ApS is recalling safeCLINITUBES Blood Samplers (REF 942-892; D957P-70-100x1) due to a defect in the product's aspiration capabilities. The recall involves 1,314 units with lot numbers R2425 through R2524.
The defect may result in the loss of blood samples. The affected products were distributed in the United States and in numerous countries internationally, including Australia, Austria, Brazil, Canada, China, and the United Kingdom.
Consumers and healthcare facilities should stop using the affected safeCLINITUBES Blood Samplers and contact Radiometer Medical ApS for further instructions or a replacement.
The recalled product
- Product
- safeCLINITUBES Blood Sampler;REF 942-892;D957P-70-100x1
- Manufacturer
- Radiometer Medical ApS
- Affected units
- 1,314
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 numbers:R2425 - R2524
Distribution
Part of a larger recall action
This product is one of 3 recalled by Radiometer Medical ApS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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