CLASS II Drug recall · Reported 16 Jan 2019 · 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 1.5% Dextrose UltraBag, distributed nationwide in the US. The recall was initiated on 2 Jan 2019 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-0351-2019
- FDA event ID
- 81881
- Recalling firm
- Baxter Healthcare, Deerfield, IL
- Manufacturer
- Vantive US Healthcare LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jan 2019
- FDA classified
- 8 Jan 2019
- Reported
- 16 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Jan 2019 | Recall initiated by company | |
| 8 Jan 2019 | Classified by FDA | +6 days |
| 16 Jan 2019 | 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: Confirmed customer complaints for leaks on the tubing.
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 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.
Where it was distributed
Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Which lots are affected?
Lot #: Y281477, Expiry: 02/2020
Where was it sold?
Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
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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