CLASS II ONGOING Device recall · Reported 19 Oct 2022 · FDA Enforcement Report

Prismaflex ST Set: ST60 (product recalled by Baxter Healthcare

Baxter Healthcare is recalling Prismaflex ST Set: ST60 (product, distributed nationwide in the US. The recall was initiated on 14 Sep 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 07332414075682 (product code 107643), 07332414075613 (product code 107636), 07332414075651 (product code 107640); All Lot Codes

Quantity recalled1,068,560 devices

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-0084-2023
FDA event ID: 90841
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 14 Sep 2022
FDA classified: 12 Oct 2022
Reported: 19 Oct 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

14 Sep 2022	Recall initiated by company
12 Oct 2022	Classified by FDA	+28 days
19 Oct 2022	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

Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Extonian (Eesti) text. The mistranslation indicates contradictory information related to the patient body weight restrictions.

Product as listed by the FDA

Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product code 107640). For use in providing continuous fluid management and renal replacement therapies.

Where it was distributed

US Nationwide

Nationwide

Questions about this recall

Is Prismaflex ST Set: ST60 (product recalled?

Yes. Baxter Healthcare recalled Prismaflex ST Set: ST60 (product on 14 Sep 2022. The recall is Class II and its status is Ongoing. Recall number Z-0084-2023.

Why was it recalled?

Which lots are affected?

UDI: 07332414075682 (product code 107643), 07332414075613 (product code 107636), 07332414075651 (product code 107640); All Lot Codes

Where was it sold?

US Nationwide

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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