Drug recall: DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II…
Class II FDA enforcement event 92931. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
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 drug recall on 11 Aug 2023. The firm address in the FDA record is in Deerfield, IL. FDA put the recall in Class II. FDA event 92931 has 2 product records. The first FDA enforcement report date is 6 Sep 2023. The record gives the status Terminated, with the termination date 16 Jul 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.
Nationwide in the USA
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
2 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1140-2023 | DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC… | a) 44,520; b) 60,762; c) 483,912 | Class II | Terminated | 6 Sep 2023 |
| D-1141-2023 | Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07 | 22,112 bags | Class II | Terminated | 6 Sep 2023 |
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
- Drug events that started in 2023
- 281
- Share of these events in Class II
- 59%
- Product records in this event
- 2Median of the firm: 1
- Events of the firm on the register
- 193
Other events of the firm
Official channels
- FDA enforcement report D-1140-2023The 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 92931. https://recallregister.com/fda/ii/92931/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA drug 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:
Nationwide in the USA
- What quantity of product is in FDA event 92931?
- The event has 2 product records. The first record gives this quantity:
a) 44,520; b) 60,762; c) 483,912
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many drug recalls of 2023 have the same class?
- 59% of the 281 drug events that started in 2023 are in Class II.