CLASS II Device recall · Reported 6 May 2020 · FDA Enforcement Report

Prismaflex System, Prismaflex Control Unit recalled by Baxter Healthcare

Baxter Healthcare is recalling Prismaflex System, Prismaflex Control Unit, distributed in Puerto Rico. The recall was initiated on 6 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code:115269; GTIN 07332414117702
Quantity recalled555

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-1831-2020
FDA event ID
85007
Recalling firm
Baxter Healthcare, Deerfield, IL
Classification
Class II
Status
Terminated
Recall initiated
6 Feb 2020
FDA classified
30 Apr 2020
Reported
6 May 2020
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

6 Feb 2020Recall initiated by company
30 Apr 2020Classified by FDA+84 days
6 May 2020Published in enforcement report+6 days

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

Reason for recall

Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

Product as listed by the FDA

Prismaflex System, Prismaflex Control Unit

Where it was distributed

Distribution in US, Puerto Rico

Puerto Rico

Questions about this recall

Is Prismaflex System, Prismaflex Control Unit recalled?

Yes. Baxter Healthcare recalled Prismaflex System, Prismaflex Control Unit on 6 Feb 2020. The recall is Class II and its status is Terminated. Recall number Z-1831-2020.

Why was it recalled?

Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

Which lots are affected?

Product Code:115269; GTIN 07332414117702

Where was it sold?

Distribution in US, Puerto Rico

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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