The Recall Desk
HighFDA (Devices)·Z-0094-2022·Announced 2021-10-20

Smiths Medical blood sampling system recalled for pressure measurement errors

Smiths Medical is recalling 3,100 units of its CBSS blood sampling system due to pressure measurement failures. The devices may show incorrect pressure readings or experience pressure shifts during use.

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: FDA Class II recall of a blood sampling device with reported measurement failures (pressure shifts and incorrect pressure readings) that pose a potential safety risk. No illnesses, injuries, or adverse outcomes have been reported, which per the rubric keeps this at the High level rather than Severe.

Plain-English summary

Smiths Medical ASD Inc. is recalling approximately 3,100 units of the MEDEX CBSS 2-fach Druckmesset mit Option blood sampling system (Model Number DPSHC0076) distributed to multiple countries.

The recalled devices may experience pressure shifts and display incorrect pressure readings during use. These measurement failures could compromise the accuracy of blood collection procedures.

The affected units were distributed to Austria, France, Germany, Great Britain, and Saudi Arabia. The recall applies to all codes of this model.

Healthcare facilities and users of these devices should contact Smiths Medical ASD Inc. for instructions on replacement or device management.

The recalled product

Product
smiths medical medex CBSS 2-fach Druckmesset mit Option, Model Number DPSHC0076
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Blood Sampling / Collection
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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