DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Reported: September 6, 2023 Initiated: August 11, 2023 #D-1140-2023
Product Description
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Reason for Recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- a) 44,520; b) 60,762; c) 483,912
- Distribution
- Nationwide in the USA
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Container bag, Product Code L5B4825, NDC 0941-0409-06; b) 5000 mL AMBU-FLEX II Container bag, Product Code L5B4826, NDC 0941-0409-07; and c) 6000 mL AMBU-FLEX II Container bag, Product Code L5B9770, NDC 0941-0409-01, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.. Recalled by Baxter Healthcare Corporation. Units affected: a) 44,520; b) 60,762; c) 483,912.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 6, 2023. Severity: Moderate. Recall number: D-1140-2023.
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