The Recall Desk
ModerateFDA (Devices)·Z-2248-2020·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, potentially resulting in lost samples.

What this means for you

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 the hazard involves lost samples rather than direct physical injury or death, fitting the criteria for a moderate severity recall involving potential adverse health consequences that are temporary or reversible.

Plain-English summary

Radiometer Medical ApS is recalling 269 units of safeCLINITUBES Blood Samplers (REF 942-898; D957P-70-70x1). The recall covers lot numbers R1431 through R1495.

The recall was initiated because the blood samplers may have insufficient aspiration capabilities, which could ultimately result in lost samples. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected products 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 in numerous countries outside the U.S., including Australia, Austria, Brazil, Canada, China, and the United Kingdom. Users should stop using the affected units and contact the manufacturer for further instructions.

The recalled product

Product
safeCLINITUBES Blood Sampler;REF 942-898;D957P-70-70x1
Manufacturer
Radiometer Medical ApS
Category
Medical Device — Blood Sampling
Hazard
Affected units
269

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: R1431 - R1495

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 →

Related recalls

Same manufacturer · Radiometer Medical ApS

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Same hazard · sample loss

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