CLASS II ONGOING Drug recall · Reported 17 Jul 2024 · FDA Enforcement Report
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis recalled
Baxter Healthcare is recalling Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For, distributed nationwide in the US. The recall was initiated on 17 Jun 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0587-2024
- FDA event ID
- 94846
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Manufacturer
- Vantive US Healthcare LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Jun 2024
- FDA classified
- 6 Jul 2024
- Reported
- 17 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Jun 2024 | Recall initiated by company | |
| 6 Jul 2024 | Classified by FDA | +19 days |
| 17 Jul 2024 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01
Where it was distributed
US Nationwide, Canada
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Which lots are affected?
Lot R24B25FA; Exp. 2/28/2026
Where was it sold?
US Nationwide, Canada
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
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.
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