Dianeal Pd-2 With Dextrose Injection, Solution
FDA Recall NDC 0941-0413

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 9 recorded enforcement report(s) associated with Dianeal Pd-2 With Dextrose (NDC 0941-0413). A significant event, classified as Class II, was initiated on Jun 17, 2024 by Vantive Us Healthcare Llc. The reported reason for this action was: "Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component."

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

D-0587-2024ONGOINGD-1141-2023TERMINATEDD-1140-2023TERMINATEDD-0543-2023COMPLETEDD-0542-2023COMPLETEDD-0351-2019TERMINATEDD-1610-2014TERMINATEDD-1276-2014TERMINATEDD-831-2013TERMINATED

June 2024 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0587-2024
Class II Ongoing
Reason for Recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Connector Assembly component.
Initiated
Jun 17, 2024
Reported
Jul 17, 2024
Quantity
6,874 bags

Recall Profile & Regulatory Data

Event ID
94846
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide, Canada
Product Description
Dianeal 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: 0941-0457-01
Batch or Lot Expiration Information
Lot# Lot R24B25FA; Exp. 2/28/2026
Affected Packages Involved in this Recall
0941-0411-05Product
0941-0411-06Product
0941-0411-07Product
0941-0411-04Product
0941-0411-11Product
0941-0413-05Product
0941-0413-06Product
0941-0413-07Product
0941-0413-01Product
0941-0413-04Product
0941-0415-05Product
0941-0415-06Product
0941-0415-04Product
0941-0415-07Product
0941-0415-01Product
0941-0409-06Product
0941-0409-05Product
0941-0409-07Product
0941-0409-01Product
0941-0457-08Product
0941-0457-02Product
0941-0457-05Product
0941-0457-01Product
0941-0459-08Product
0941-0459-02Product
0941-0459-05Product
0941-0459-01Product
0941-0426-52Product
0941-0426-53Product
0941-0427-52Product
0941-0427-53Product
0941-0429-52Product
0941-0429-53Product
0941-0424-51Product
0941-0424-52Product
0941-0424-53Product
0941-0430-51Product
0941-0430-52Product
0941-0430-53Product
0941-0433-51Product
0941-0433-52Product
0941-0433-53Product
0941-0484-01Product
0941-0487-01Product
0941-0490-01Product

August 2023 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-1141-2023
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Initiated
Aug 11, 2023
Reported
Sep 06, 2023
Quantity
22,112 bags

Recall Profile & Regulatory Data

Event ID
92931
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jul 16, 2024
Product Description
Dianeal 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 0941-0411-07
Batch or Lot Expiration Information
Lot# Lot Y406734, Exp 31-Oct-2024
Affected Packages Involved in this Recall
0941-0411-05Product
0941-0411-06Product
0941-0411-07Product
0941-0411-04Product
0941-0411-11Product
0941-0413-05Product
0941-0413-06Product
0941-0413-07Product
0941-0413-01Product
0941-0413-04Product
0941-0415-05Product
0941-0415-06Product
0941-0415-04Product
0941-0415-07Product
0941-0415-01Product
0941-0409-06Product
0941-0409-05Product
0941-0409-07Product
0941-0409-01Product
0941-0457-08Product
0941-0457-02Product
0941-0457-05Product
0941-0457-01Product
0941-0459-08Product
0941-0459-02Product
0941-0459-05Product
0941-0459-01Product
0941-0426-52Product
0941-0426-53Product
0941-0427-52Product
0941-0427-53Product
0941-0429-52Product
0941-0429-53Product
0941-0424-51Product
0941-0424-52Product
0941-0424-53Product
0941-0430-51Product
0941-0430-52Product
0941-0430-53Product
0941-0433-51Product
0941-0433-52Product
0941-0433-53Product
0941-0484-01Product
0941-0487-01Product
0941-0490-01Product

August 2023 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-1140-2023
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Initiated
Aug 11, 2023
Reported
Sep 06, 2023
Quantity
a) 44,520; b) 60,762; c) 483,912

Recall Profile & Regulatory Data

Event ID
92931
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jul 16, 2024
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.
Batch or Lot Expiration Information
Lot# a) Lots Y403948, Exp 30-Sep-2024; Lot Y406277, Exp 31-Oct-2024. b) Lot 408790, Exp 30-Nov-2024 and c) Lots Y403740, Y403740A, Exp 30-Sep-2024; Lots Y405638, Y405805, Y407304, Y407304A Exp 31-Oct-2024; Lots Y407717, Y407717A, Y408554, Exp 30-Nov-2024; Lot Y420075, Exp 30-Apr-2025
Affected Packages Involved in this Recall
0941-0411-05Product
0941-0411-06Product
0941-0411-07Product
0941-0411-04Product
0941-0411-11Product
0941-0413-05Product
0941-0413-06Product
0941-0413-07Product
0941-0413-01Product
0941-0413-04Product
0941-0415-05Product
0941-0415-06Product
0941-0415-04Product
0941-0415-07Product
0941-0415-01Product
0941-0409-06Product
0941-0409-05Product
0941-0409-07Product
0941-0409-01Product
0941-0457-08Product
0941-0457-02Product
0941-0457-05Product
0941-0457-01Product
0941-0459-08Product
0941-0459-02Product
0941-0459-05Product
0941-0459-01Product
0941-0426-52Product
0941-0426-53Product
0941-0427-52Product
0941-0427-53Product
0941-0429-52Product
0941-0429-53Product
0941-0424-51Product
0941-0424-52Product
0941-0424-53Product
0941-0430-51Product
0941-0430-52Product
0941-0430-53Product
0941-0433-51Product
0941-0433-52Product
0941-0433-53Product
0941-0484-01Product
0941-0487-01Product
0941-0490-01Product

March 2023 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0543-2023
Class II Completed
Reason for Recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Initiated
Mar 15, 2023
Reported
May 03, 2023
Quantity
9,788 bags

Recall Profile & Regulatory Data

Event ID
91883
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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.
Batch or Lot Expiration Information
Lot# Lot Y405201, Exp 31-Oct-2024
Affected Packages Involved in this Recall
0941-0411-05Product
0941-0411-06Product
0941-0411-07Product
0941-0411-04Product
0941-0411-11Product
0941-0413-05Product
0941-0413-06Product
0941-0413-07Product
0941-0413-01Product
0941-0413-04Product
0941-0415-05Product
0941-0415-06Product
0941-0415-04Product
0941-0415-07Product
0941-0415-01Product
0941-0409-06Product
0941-0409-05Product
0941-0409-07Product
0941-0409-01Product
0941-0457-08Product
0941-0457-02Product
0941-0457-05Product
0941-0457-01Product
0941-0459-08Product
0941-0459-02Product
0941-0459-05Product
0941-0459-01Product
0941-0426-52Product
0941-0426-53Product
0941-0427-52Product
0941-0427-53Product
0941-0429-52Product
0941-0429-53Product
0941-0424-51Product
0941-0424-52Product
0941-0424-53Product
0941-0430-51Product
0941-0430-52Product
0941-0430-53Product
0941-0433-51Product
0941-0433-52Product
0941-0433-53Product
0941-0484-01Product
0941-0487-01Product
0941-0490-01Product

March 2023 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0542-2023
Class II Completed
Reason for Recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Initiated
Mar 15, 2023
Reported
May 03, 2023
Quantity
a) 95,448 bags; b) 174,522 bags

Recall Profile & Regulatory Data

Event ID
91883
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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.
Batch or Lot Expiration Information
Lot# : a) Y406130, Exp 31-Oct-2024; b) Lots Y406314, Y406314A, Y406963, Y407199, Exp 31-Oct-2024
Affected Packages Involved in this Recall
0941-0411-05Product
0941-0411-06Product
0941-0411-07Product
0941-0411-04Product
0941-0411-11Product
0941-0413-05Product
0941-0413-06Product
0941-0413-07Product
0941-0413-01Product
0941-0413-04Product
0941-0415-05Product
0941-0415-06Product
0941-0415-04Product
0941-0415-07Product
0941-0415-01Product
0941-0409-06Product
0941-0409-05Product
0941-0409-07Product
0941-0409-01Product
0941-0457-08Product
0941-0457-02Product
0941-0457-05Product
0941-0457-01Product
0941-0459-08Product
0941-0459-02Product
0941-0459-05Product
0941-0459-01Product
0941-0426-52Product
0941-0426-53Product
0941-0427-52Product
0941-0427-53Product
0941-0429-52Product
0941-0429-53Product
0941-0424-51Product
0941-0424-52Product
0941-0424-53Product
0941-0430-51Product
0941-0430-52Product
0941-0430-53Product
0941-0433-51Product
0941-0433-52Product
0941-0433-53Product
0941-0484-01Product
0941-0487-01Product
0941-0490-01Product

January 2019 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0351-2019
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing.
Initiated
Jan 02, 2019
Reported
Jan 16, 2019
Quantity
29,370 bags

Recall Profile & Regulatory Data

Event ID
81881
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA to Wholesaler/Distributors, Healthcare Facilities and Home Patients.
Termination Date
Apr 29, 2020
Product Description
Dianeal 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.
Batch or Lot Expiration Information
Lot# : Y281477, Expiry: 02/2020
Affected Packages Involved in this Recall
0941-0411-05Product
0941-0411-06Product
0941-0411-07Product
0941-0411-04Product
0941-0411-11Product
0941-0413-05Product
0941-0413-06Product
0941-0413-07Product
0941-0413-01Product
0941-0413-04Product
0941-0415-05Product
0941-0415-06Product
0941-0415-04Product
0941-0415-07Product
0941-0415-01Product
0941-0409-06Product
0941-0409-05Product
0941-0409-07Product
0941-0409-01Product
0941-0457-08Product
0941-0457-02Product
0941-0457-05Product
0941-0457-01Product
0941-0459-08Product
0941-0459-02Product
0941-0459-05Product
0941-0459-01Product
0941-0426-52Product
0941-0426-53Product
0941-0427-52Product
0941-0427-53Product
0941-0429-52Product
0941-0429-53Product
0941-0424-51Product
0941-0424-52Product
0941-0424-53Product
0941-0430-51Product
0941-0430-52Product
0941-0430-53Product
0941-0433-51Product
0941-0433-52Product
0941-0433-53Product
0941-0484-01Product
0941-0487-01Product
0941-0490-01Product

August 2014 Class I Recall: Presence of Particulate Matter

Recall Number
D-1610-2014
Class I Terminated
Reason for Recall
Presence of Particulate Matter: particulate matter was found during the manufacturing process.
Initiated
Aug 07, 2014
Reported
Oct 08, 2014
Quantity
50,530 bags

Recall Profile & Regulatory Data

Event ID
69011
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 28, 2017
Product Description
Dianeal 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.
Batch or Lot Expiration Information
Lot# : C940700, C940841, Exp 05/16
Affected Packages Involved in this Recall
0941-0411-05Product
0941-0411-06Product
0941-0411-07Product
0941-0411-04Product
0941-0411-11Product
0941-0413-05Product
0941-0413-06Product
0941-0413-07Product
0941-0413-01Product
0941-0413-04Product
0941-0415-05Product
0941-0415-06Product
0941-0415-04Product
0941-0415-07Product
0941-0415-01Product
0941-0409-06Product
0941-0409-05Product
0941-0409-07Product
0941-0409-01Product
0941-0457-08Product
0941-0457-02Product
0941-0457-05Product
0941-0457-01Product
0941-0459-08Product
0941-0459-02Product
0941-0459-05Product
0941-0459-01Product
0941-0426-52Product
0941-0426-53Product
0941-0427-52Product
0941-0427-53Product
0941-0429-52Product
0941-0429-53Product
0941-0424-51Product
0941-0424-52Product
0941-0424-53Product
0941-0430-51Product
0941-0430-52Product
0941-0430-53Product
0941-0433-51Product
0941-0433-52Product
0941-0433-53Product
0941-0484-01Product
0941-0487-01Product
0941-0490-01Product

February 2014 Class I Recall: Non-Sterility

Recall Number
D-1276-2014
Class I Terminated
Reason for Recall
Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag and the overpouch.
Initiated
Feb 11, 2014
Reported
May 07, 2014
Quantity
27,169 containers

Recall Profile & Regulatory Data

Event ID
67608
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Jul 22, 2015
Product Description
Dianeal 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 0941-0411-11
Batch or Lot Expiration Information
Lot# Lot number: C903799, Exp 05/15
Affected Packages Involved in this Recall
0941-0411-05Product
0941-0411-06Product
0941-0411-07Product
0941-0411-04Product
0941-0411-11Product
0941-0413-05Product
0941-0413-06Product
0941-0413-07Product
0941-0413-01Product
0941-0413-04Product
0941-0415-05Product
0941-0415-06Product
0941-0415-04Product
0941-0415-07Product
0941-0415-01Product
0941-0409-06Product
0941-0409-05Product
0941-0409-07Product
0941-0409-01Product
0941-0457-08Product
0941-0457-02Product
0941-0457-05Product
0941-0457-01Product
0941-0459-08Product
0941-0459-02Product
0941-0459-05Product
0941-0459-01Product
0941-0426-52Product
0941-0426-53Product
0941-0427-52Product
0941-0427-53Product
0941-0429-52Product
0941-0429-53Product
0941-0424-51Product
0941-0424-52Product
0941-0424-53Product
0941-0430-51Product
0941-0430-52Product
0941-0430-53Product
0941-0433-51Product
0941-0433-52Product
0941-0433-53Product
0941-0484-01Product
0941-0487-01Product
0941-0490-01Product

July 2013 Class II Recall: Defective Container

Recall Number
D-831-2013
Class II Terminated
Reason for Recall
Defective Container: There is a potential for frangible components to be broken, resulting in a leak at the port when the closure is removed.
Initiated
Jul 24, 2013
Reported
Aug 07, 2013
Quantity
39,486 containers

Recall Profile & Regulatory Data

Event ID
65784
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Jun 24, 2014
Product Description
DIANEAL 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 0941-0409-07
Batch or Lot Expiration Information
Lot# Product Code: L5B4826
Lot# : C886820, Exp 11/14
Affected Packages Involved in this Recall
0941-0411-05Product
0941-0411-06Product
0941-0411-07Product
0941-0411-04Product
0941-0411-11Product
0941-0413-05Product
0941-0413-06Product
0941-0413-07Product
0941-0413-01Product
0941-0413-04Product
0941-0415-05Product
0941-0415-06Product
0941-0415-04Product
0941-0415-07Product
0941-0415-01Product
0941-0409-06Product
0941-0409-05Product
0941-0409-07Product
0941-0409-01Product
0941-0457-08Product
0941-0457-02Product
0941-0457-05Product
0941-0457-01Product
0941-0459-08Product
0941-0459-02Product
0941-0459-05Product
0941-0459-01Product
0941-0426-52Product
0941-0426-53Product
0941-0427-52Product
0941-0427-53Product
0941-0429-52Product
0941-0429-53Product
0941-0424-51Product
0941-0424-52Product
0941-0424-53Product
0941-0430-51Product
0941-0430-52Product
0941-0430-53Product
0941-0433-51Product
0941-0433-52Product
0941-0433-53Product
0941-0484-01Product
0941-0487-01Product
0941-0490-01Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.