CLASS II Device recall · Reported 31 Mar 2021 · FDA Enforcement Report

Preventative Maintenance Kits G5010007) and spare part kits recalled

Baxter Healthcare is recalling Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203), distributed nationwide in the US. The recall was initiated on 28 Jan 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesall serial numbers

Quantity recalled35175 kits

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-1280-2021
FDA event ID: 87299
Recalling firm: Baxter Healthcare, Deerfield, IL
Classification: Class II
Status: Terminated
Recall initiated: 28 Jan 2021
FDA classified: 19 Mar 2021
Reported: 31 Mar 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

28 Jan 2021	Recall initiated by company
19 Mar 2021	Classified by FDA	+50 days
31 Mar 2021	Published in enforcement report	+12 days

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

Reason for recall

Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT).

Where it was distributed

Worldwide distribution - US Nationwide distribution including Puerto Rico and Guam and the countries of Albania, Algeria, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia Herzegovina, Bulgaria, Canada, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Ivory Coast, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxemburg, Macedonia, Malta, Mauritius, Montenegro, Morocco, Netherlands, Nigeria, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sudan, Syria, Sweden, Switzerland, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Yemen, Australia, New Zealand, China, Japan, Korea, Taiwan, Hong Kong, India, Thailand, Singapore, Malaysia, Vietnam, Grand Cayman, Dominican Republic, St. Kitts, Venezuela, Argentina, Chile, Barbados, Bermuda, Costa Rica, Cuba, Haiti, Guatemala, Colombia, Trinidad & Tobago, Mexico, and Brazil.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.

Which lots are affected?

all serial numbers

Where was it sold?

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

3 other products · FDA event 87299

This product is part of a recall event; the main page for the event is Prismaflex Control Unit recalled by Baxter Healthcare.

Reported	Class	Recall	Company	Reason	Where
31 Mar 2021	CLASS II	Prismaflex Control Unit recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
31 Mar 2021	CLASS II	Prismaflex Control Unit recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
31 Mar 2021	CLASS II	Prismaflex Control Unit recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide

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