CLASS I Drug recall · Reported 8 Oct 2014 · 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 Ambu-Flex, distributed nationwide in the US. The recall was initiated on 7 Aug 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-1610-2014
- FDA event ID
- 69011
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Manufacturer
- Vantive US Healthcare LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 7 Aug 2014
- FDA classified
- 26 Sep 2014
- Reported
- 8 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 7 Aug 2014 | Recall initiated by company | |
| 26 Sep 2014 | Classified by FDA | +50 days |
| 8 Oct 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
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Product as listed by the FDA
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Which lots are affected?
Lot #: C940700, C940841, Exp 05/16
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 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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