Dianeal 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.
Reported: May 3, 2023 Initiated: March 15, 2023 #D-0542-2023
Product Description
Dianeal 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.
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) 95,448 bags; b) 174,522 bags
- Distribution
- Nationwide in the USA
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Dianeal 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.. Recalled by Baxter Healthcare Corporation. Units affected: a) 95,448 bags; b) 174,522 bags.
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 May 3, 2023. Severity: Moderate. Recall number: D-0542-2023.
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