← FDA ENFORCEMENT
D-0587-2024Class II

Baxter Healthcare Corporation

Recalling firm
Baxter Healthcare Corporation
Product type
Drug
Status
Ongoing
Report date
2024-07-17
Distribution
US Nationwide, Canada
Firm state
IL
Product quantity
6,874 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

Product description

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

Code / lot info

Lot R24B25FA; Exp. 2/28/2026

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.