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Drug FDA Class II Ongoing Contamination / non-sterility

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

Baxter Healthcare Corporation Published Jul 17, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Baxter Healthcare Corporation or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.

Hazards

Potential Microbial Contamination from Leaking Connector Assembly · primary

Affected products (1)

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

DIANEAL LOW CALCIUM WITH DEXTROSE · 6,874 bags

NDC: 0941-0409, 0941-0411, 0941-0413, 0941-0415, 0941-0457, 0941-0459, 0941-0426, 0941-0427, 0941-0429, 0941-0424, 0941-0430, 0941-0433, 0941-0484, 0941-0487, 0941-0490, 0941-0411-05, 0941-0411-06, 0941-0411-07, 0941-0411-04, 0941-0411-11, 0941-0413-05, 0941-0413-06, 0941-0413-07, 0941-0413-01, 0941-0413-04, 0941-0415-05, 0941-0415-06, 0941-0415-04, 0941-0415-07, 0941-0415-01, 0941-0409-06, 0941-0409-05, 0941-0409-07, 0941-0409-01, 0941-0457-08, 0941-0457-02, 0941-0457-05, 0941-0457-01, 0941-0459-08, 0941-0459-02, 0941-0459-05, 0941-0459-01, 0941-0426-52, 0941-0426-53, 0941-0427-52, 0941-0427-53, 0941-0429-52, 0941-0429-53, 0941-0424-51, 0941-0424-52, 0941-0424-53, 0941-0430-51, 0941-0430-52, 0941-0430-53, 0941-0433-51, 0941-0433-52, 0941-0433-53, 0941-0484-01, 0941-0487-01, 0941-0490-01
Lot codes: R24B25FA
Code info: Lot R24B25FA; Exp. 2/28/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 17, 2024
  2. Published
    Jul 17, 2024
Recall number
D-0587-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.