The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2249-2020·Announced 2020-06-10

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, but the source text explicitly states the consequence is 'lost samples' with no reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a functional defect without immediate health harm.

Plain-English summary

Radiometer Medical ApS is recalling safeCLINITUBES Blood Samplers (REF 942-969; D957P-70-45x1) due to a defect in the product's aspiration capabilities. The recall involves 5 units with lot numbers R0291 through R0301.

The FDA classifies this as a Class II recall. The source text states that the samplers may have insufficient aspiration capabilities, which ultimately results in lost samples. No injuries or illnesses are reported in the source text.

The affected units were distributed in the United States (including AK, AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, and WI) and internationally to numerous countries including Australia, Austria, Brazil, Canada, China, and the United Kingdom. Users should stop using the affected samplers and contact the manufacturer for further instructions.

The recalled product

Product
safeCLINITUBES Blood Sampler;REF 942-969;D957P-70-45x1
Manufacturer
Radiometer Medical ApS
Category
Medical Device — Blood Collection
Hazard
Affected units
5

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: R0291 - R0301

Distribution

Distributed in 38 states:

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.

See all 3 products in this recall →

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