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  5. FDA Recall: Dianeal Pd-2 With Dextrose

FDA Recall Dianeal Pd-2 With Dextrose

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The most recent Recall Enforcement Report that covers this product was initiated on June 17th, 2024 and classified as a Class II recall due to lack of assurance of sterility: potential presence of leaks originating from the connector assembly component. This recall is currently ongoing, and the associated recall number is recall number is D-0587-2024. It pertains to Dianeal Pd-2 With Dextrose identified by 0941-0426.

Recall Number Recall Initiation Date Report Date Quantity Product Description Recall Reason Status
D-0587-202406-17-202407-17-20246,874 bagsDianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, For Intraperitoneal Administration Only, 6000 mL per bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. NDC: 0941-0457-01Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.Ongoing
D-1141-202308-11-202309-06-202322,112 bagsDianeal 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 0941-0411-07Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.Terminated
D-1140-202308-11-202309-06-2023a) 44,520; b) 60,762; c) 483,912DIANEAL 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.Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.Terminated
D-0543-202303-15-202305-03-20239,788 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-0542-202303-15-202305-03-2023a) 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
D-0351-201901-02-201901-16-201929,370 bagsDianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.Terminated
D-1610-201408-07-201410-08-201450,530 bagsDianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code L5B5202, NDC 0941-0457-05.Presence of Particulate Matter: particulate matter was found during the manufacturing process.Terminated
D-1276-201402-11-201405-07-201427,169 containersDianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Flex II container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code L5B9710, NDC 0941-0411-11Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.Terminated
D-831-201307-24-201308-07-201339,486 containersDIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product L5B4826, NDC 0941-0409-07Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.Terminated

What is a Recall Enforcement Report?

A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.

When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.

The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.

Understanding Recall Reports

The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.

Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.

If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.