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.
Reported: May 3, 2023 Initiated: March 15, 2023 #D-0543-2023
Product Description
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.
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
- 9,788 bags
- Distribution
- Nationwide in the USA
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Baxter Healthcare Corporation. Units affected: 9,788 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-0543-2023.
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