CLASS II Drug recall · Reported 6 Sep 2023 · FDA Enforcement Report
Dianeal PD-2 Peritonial Dialysis Solution recalled by Baxter Healthcare
Baxter Healthcare is recalling Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose Ambu-flex ll Container with, distributed nationwide in the US. The recall was initiated on 11 Aug 2023 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-1141-2023
- FDA event ID
- 92931
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Manufacturer
- Vantive US Healthcare LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Aug 2023
- FDA classified
- 29 Aug 2023
- Reported
- 6 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Aug 2023 | Recall initiated by company | |
| 29 Aug 2023 | Classified by FDA | +18 days |
| 6 Sep 2023 | Published in enforcement report | +8 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 Luer 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 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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Which lots are affected?
Lot Y406734, Exp 31-Oct-2024
Where was it sold?
Nationwide in the USA
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.
Other products in this recall event
1 other product · FDA event 92931| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis recalledDianeal Low Calcium With Dextrose | Baxter Healthcare | Sterility | Nationwide |
More recalls from Baxter Healthcare
All 577| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | PRO+ 36" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Pro+ Mrs Surface For Versacare, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Device | CLASS II | Volara System Volara, HC, NA recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | PRO+ 40" MRS Surface, mattress recalled by Baxter Healthcare | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
Other Sodium Chloride recalls
All 133| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | 0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | 0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Drug | CLASS I | Lactated Ringer's Injection USP Excel container recalledLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | Lactated Ringer's Injection USP container recalled by B Braun MedicalLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS II | Lactated Ringer's Irrigation, Sterile, Ex only recalledLactated Ringers Irrigation | B Braun Medical | Sterility | Nationwide |