The Recall Desk
HighFDA (Devices)·Z-0101-2022·Announced 2021-10-20

Blood sampling system sets recalled for pressure reading and measurement errors

Smiths Medical is recalling its medex blood sampling system sets due to pressure shifts and incorrect readings that may affect sample collection accuracy.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II device recall with no reported illnesses or injuries. The hazard is a functional defect affecting pressure accuracy in a blood sampling device, which is a risk-of-harm medical device. Per the rubric, recalls involving risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Smiths Medical ASD Inc. is recalling 150 units of its medex CBSS-5ML blood sampling system sets (Model Number DPSHC0092) distributed internationally.

The devices have been reported to exhibit pressure shifts and provide incorrect pressure readings during blood sampling procedures. These functional issues may affect the accuracy and reliability of the blood collection process.

The affected sets were distributed to medical facilities in Austria, France, Germany, Great Britain, and Saudi Arabia. All product codes are included in this recall.

The recalled product

Product
smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Blood Sampling
Hazard
  • pressure-shift
  • measurement-error

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)

  • All codes

Distribution

Distribution scope not specified by the agency.

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