CLASS II Device recall · Reported 20 Oct 2021 · FDA Enforcement Report

smiths medical medex CBSS-, Single Set recalled

Smiths Medical ASD is recalling smiths medical medex CBSS-, Single Set. The recall was initiated on 10 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll codes

Quantity recalled13620 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0102-2022
FDA event ID: 88667
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class II
Status: Terminated
Recall initiated: 10 Mar 2020
FDA classified: 13 Oct 2021
Reported: 20 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Mar 2020	Recall initiated by company
13 Oct 2021	Classified by FDA	+582 days
20 Oct 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

Product as listed by the FDA

smiths medical medex CBSS-5ML, Single Set, (172/15cm), Model Number DPSHC0093

Where it was distributed

Austria, France, Germany, Great Britain, and Saudi Arabia

Questions about this recall

Is smiths medical medex CBSS-, Single Set recalled?

Yes. Smiths Medical ASD recalled smiths medical medex CBSS-, Single Set on 10 Mar 2020. The recall is Class II and its status is Terminated. Recall number Z-0102-2022.

Why was it recalled?

Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.

Which lots are affected?

All codes

Where was it sold?

Austria, France, Germany, Great Britain, and Saudi Arabia

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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