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

Prismaflex M Set: M60 (product recalled by Baxter Healthcare

Baxter Healthcare is recalling Prismaflex M Set: M60 (, 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: 07332414064549 (product code 106696), 07332414064556 (product code 106697); All lot codes

Quantity recalled524,376 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-0081-2023
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 M Set: M60 (product code 106696), M100 (product code 106697). For use in providing continuous fluid management and renal replacement therapies.

Where it was distributed

US Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

UDI: 07332414064549 (product code 106696), 07332414064556 (product code 106697); 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 90841

This product is part of a recall event; the main page for the event is Prismaflex HF20 Set (product recalled by Baxter Healthcare.

Reported	Class	Recall	Company	Reason	Where
19 Oct 2022	CLASS II	Prismaflex HF20 Set (product recalled by Baxter Healthcare	Baxter Healthcare	Other	Nationwide
19 Oct 2022	CLASS II	Prismaflex ST Set: ST60 (product recalled by Baxter Healthcare	Baxter Healthcare	Other	Nationwide
19 Oct 2022	CLASS II	Prismaflex M Set: M150 (product recalled by Baxter Healthcare	Baxter Healthcare	Other	Nationwide
19 Oct 2022	CLASS II	Prismaflex HF Set: HF1000 (product recalled by Baxter Healthcare	Baxter Healthcare	Other	Nationwide

More recalls from Baxter Healthcare

All 572

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	Dextrose Injection, USP, 70 % recalled by Baxter Healthcare	Baxter Healthcare	Particulate Matter	Nationwide
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9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Drug	CLASS II	Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide

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