The Recall Desk
HighFDA (Devices)·Z-0098-2022·Announced 2021-10-20

Medical Device Recall: Blood Sampling System Pressure and Reading Errors

Smiths Medical is recalling LogiCal Closed Blood Sampling System sets due to reported pressure shifts and incorrect pressure readings that could affect blood 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: FDA Class II recall of a medical device with reported functional malfunctions in blood sampling. No illnesses or injuries have been reported in the source text, but measurement errors in blood collection systems pose inherent risk of compromising clinical care decisions.

Plain-English summary

Smiths Medical ASD Inc. is recalling LogiCal Closed Blood Sampling System sets (Model Number DPSHC0084) distributed in Austria, France, Germany, Great Britain, and Saudi Arabia. Approximately 1,420 units are affected by this recall.

The recall was initiated due to reported pressure shifts and incorrect pressure readings in the sampling systems. These malfunctions could potentially affect the accuracy of blood collection procedures.

The FDA classified this as a Class II recall, indicating potential for serious adverse health consequences or clinical impact.

The recalled product

Product
smiths medical medex CBSS 5 ml, zweifach proximaler Entnahmeport 60 cm, Model Number DPSHC0084
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Blood Sampling
Hazard
  • pressure-malfunction
  • 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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