← FDA ENFORCEMENT
D-1141-2023Class II

Baxter Healthcare Corporation

Recalling firm
Baxter Healthcare Corporation
Product type
Drug
Status
Terminated
Report date
2023-09-06
Distribution
Nationwide in the USA
Firm state
IL
Product quantity
22,112 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 Luer component.

Product description

Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product code L5B5193 NDC 0941-0411-07

Code / lot info

Lot Y406734, Exp 31-Oct-2024

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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.