The Recall Desk
HighFDA (Devices)·Z-0099-2022·Announced 2021-10-20

Smiths Medical closed blood sampling system sets recalled for pressure reading errors

Smiths Medical is recalling CBSS-5ML blood sampling system sets due to reported pressure shifts and incorrect pressure readings that may affect the accuracy of blood sample collection.

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 recall of a medical device with reported pressure shifts and incorrect readings that could compromise sample integrity and patient safety. No adverse events are documented in the source material, placing this at score 3 per the rubric: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smiths Medical ASD Inc. is recalling the Medex CBSS-5ML Zweifach closed blood sampling system sets, Model Number DPSHC0090. The devices have been reported to experience pressure shifts and incorrect pressure readings.

These issues may compromise the accuracy and integrity of blood samples collected using the affected devices. The affected units were distributed in Austria, France, Germany, Great Britain, and Saudi Arabia.

Healthcare facilities and clinicians using these devices should discontinue use immediately and contact Smiths Medical ASD Inc. for instructions regarding replacement or return of the affected units.

The recalled product

Product
smiths medical medex CBSS-5ML Zweifach set, Model Number DPSHC0090
Manufacturer
Smiths Medical ASD Inc.
Category
Medical Device — Blood Sampling System
Hazard
  • pressure-shift
  • incorrect-readings

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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