CLASS I Drug recall · Reported 7 May 2014 · FDA Enforcement Report
Dianeal PD-2 Peritoneal Dialysis Solution recalled by Baxter Healthcare
Baxter Healthcare is recalling Dianeal PD-2 Peritoneal Dialysis Solution with 5% Dextrose Ambu-Flex II container, distributed nationwide in the US. The recall was initiated on 11 Feb 2014 and the FDA has classified it as Class I.
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-1276-2014
- FDA event ID
- 67608
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Manufacturer
- Vantive US Healthcare LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 11 Feb 2014
- FDA classified
- 25 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Drug class
- Injectable & IV Drugs
Timeline
| 11 Feb 2014 | Recall initiated by company | |
| 25 Apr 2014 | Classified by FDA | +73 days |
| 7 May 2014 | 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
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Product as listed by the FDA
Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11
Where it was distributed
Nationwide.
Questions about this recall
Is Dianeal PD-2 Peritoneal Dialysis Solution with 5% Dextrose Ambu-Flex II container recalled?
Yes. Baxter Healthcare recalled Dianeal PD-2 Peritoneal Dialysis Solution with 5% Dextrose Ambu-Flex II container on 11 Feb 2014. The recall is Class I and its status is Terminated. Recall number D-1276-2014.
Why was it recalled?
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Which lots are affected?
Lot number: C903799, Exp 05/15
Where was it sold?
Nationwide.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Baxter Healthcare
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|---|---|---|---|---|---|
| Drug | CLASS I | Dextrose Injection, USP, 70 % recalled by Baxter Healthcare | Baxter Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS I | 9% Sodium Chloride Injection USP, Viaflex recalled by Baxter HealthcareSodium Chloride | Baxter Healthcare | Particulate Matter | IL |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Drug | CLASS II | Clindamycin Phosphate in 9% Sodium Chloride Injection recalledClindamycin Phosphate | Baxter Healthcare | Sterility | Nationwide |
Other Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dianeal Low Calcium 5 mEq/L) Peritoneal Dialysis Solution recalledDianeal Low Calcium With Dextrose | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Dianeal Low Calcium 5 mEq/L) Peritoneal Dialysis Solution recalledDianeal Low Calcium With Dextrose | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Dianeal PD-2 Peritonial Dialysis Solution recalled by Baxter HealthcareDianeal Low Calcium With Dextrose | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Dianeal Low Calcium 5 mEq/L) Peritonial Dialysis Solution recalledDianeal Low Calcium With Dextrose | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Dianeal PD-2 Peritonial Dialysis Solution recalled by Baxter HealthcareDianeal Low Calcium With Dextrose | Baxter Healthcare | Sterility | Nationwide |