Device recall: Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).
Class II FDA enforcement event 87299. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Baxter Healthcare Corporation started this device recall on 28 Jan 2021. The firm address in the FDA record is in Deerfield, IL. FDA put the recall in Class II. FDA event 87299 has 4 product records. The first FDA enforcement report date is 31 Mar 2021. The record gives the status Terminated, with the termination date 13 Jun 2024.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution - US Nationwide distribution including Puerto Rico and Guam and the countries of Albania, Algeria, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia Herzegovina,…
Recalling firm
Baxter Healthcare Corporation, Deerfield, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1277-2021 | Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT). | 4946 units | Class II | Terminated | 31 Mar 2021 |
| Z-1278-2021 | Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT). | 1225 units | Class II | Terminated | 31 Mar 2021 |
| Z-1279-2021 | Prismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT). | 1650 units | Class II | Terminated | 31 Mar 2021 |
| Z-1280-2021 | Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage: For Prismaflex Control Units, used for Continuous Renal Replacement Therapy (CRRT). | 35175 kits | Class II | Terminated | 31 Mar 2021 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2021
- 900
- Share of these events in Class II
- 89%
- Product records in this event
- 4Median of the firm: 1
- Events of the firm on the register
- 193
Other events of the firm
Official channels
- FDA enforcement report Z-1277-2021The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 87299. https://recallregister.com/fda/ii/87299/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution - US Nationwide distribution including Puerto Rico and Guam and the countries of Albania, Algeria, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia Herzegovina,…
- What quantity of product is in FDA event 87299?
- The event has 4 product records. The first record gives this quantity:
4946 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2021 have the same class?
- 89% of the 900 device events that started in 2021 are in Class II.