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Recall Enforment Report D-0543-2023

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Baxter Healthcare Corporation, originally initiated on 03-15-2023 for the product Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04. The product was recalled due to lack of assurance of sterility: potential presence of leaks originating from the luer component.. The product was distributed nationwide and the recall is currently completed.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0543-202303-15-202305-03-2023Class II9,788 bagsDianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.Completed
D-0542-202303-15-202305-03-2023Class IIa) 95,448 bags; b) 174,522 bagsDianeal Low Calcium (2.5 mEq/L) Peritonial Dialysis Solution with 1.5% Dextrose, packaged in a) 5000 mL per Ambu-Flex II Container bag, Product Code L5B4826, NDC 0941-0409-07; and b) 6000 mL per Ambu-Flex II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.Completed

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0941-0409Dianeal Low Calcium With Dextrose Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And DextroseInjection, SolutionIntraperitonealVantive Us Healthcare LlcHuman Prescription Drug
0941-0411Dianeal Pd-2 With Dextrose Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And DextroseInjection, SolutionIntraperitonealVantive Us Healthcare LlcHuman Prescription Drug
0941-0413Dianeal Pd-2 With Dextrose Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And DextroseInjection, SolutionIntraperitonealVantive Us Healthcare LlcHuman Prescription Drug
0941-0415Dianeal Pd-2 With Dextrose Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And DextroseInjection, SolutionIntraperitonealVantive Us Healthcare LlcHuman Prescription Drug
0941-0424Dianeal Low Calcium With Dextrose Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And DextroseInjection, SolutionIntraperitonealVantive Us Healthcare LlcHuman Prescription Drug
0941-0426Dianeal Pd-2 With Dextrose Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And DextroseInjection, SolutionIntraperitonealVantive Us Healthcare LlcHuman Prescription Drug
0941-0427Dianeal Pd-2 With Dextrose Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And DextroseInjection, SolutionIntraperitonealVantive Us Healthcare LlcHuman Prescription Drug
0941-0429Dianeal Pd-2 With Dextrose Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And DextroseInjection, SolutionIntraperitonealVantive Us Healthcare LlcHuman Prescription Drug
0941-0430Dianeal Low Calcium With Dextrose Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And DextroseInjection, SolutionIntraperitonealVantive Us Healthcare LlcHuman Prescription Drug
0941-0433Dianeal Low Calcium With Dextrose Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And DextroseInjection, SolutionIntraperitonealVantive Us Healthcare LlcHuman Prescription Drug
0941-0457Dianeal Low Calcium With Dextrose Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And DextroseInjection, SolutionIntraperitonealVantive Us Healthcare LlcHuman Prescription Drug
0941-0459Dianeal Low Calcium With Dextrose Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And DextroseInjection, SolutionIntraperitonealVantive Us Healthcare LlcHuman Prescription Drug
0941-0484Dianeal Low Calcium With Dextrose Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And DextroseInjection, SolutionIntraperitonealVantive Us Healthcare LlcHuman Prescription Drug
0941-0487Dianeal Low Calcium With Dextrose Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And DextroseInjection, SolutionIntraperitonealVantive Us Healthcare LlcHuman Prescription Drug
0941-0490Dianeal Low Calcium With Dextrose Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And DextroseInjection, SolutionIntraperitonealVantive Us Healthcare LlcHuman Prescription Drug