Recall Enforment Report D-1141-2023

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Baxter Healthcare Corporation, originally initiated on 08-11-2023 for the product 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 The product was recalled due to lack of assurance of sterility: potential presence of leaks originating from the luer component.. The product was distributed nationwide and the recall is currently completed.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-1141-2023	08-11-2023	09-06-2023	Class II	22,112 bags	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	Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.	Completed
D-1140-2023	08-11-2023	09-06-2023	Class II	a) 44,520; b) 60,762; c) 483,912	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.	Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.	Completed

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
0941-0409	Dianeal Low Calcium With Dextrose	Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose	Injection, Solution	Intraperitoneal	Baxter Healthcare Corporation	Human Prescription Drug
0941-0411	Dianeal Pd-2 With Dextrose	Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose	Injection, Solution	Intraperitoneal	Baxter Healthcare Corporation	Human Prescription Drug
0941-0413	Dianeal Pd-2 With Dextrose	Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose	Injection, Solution	Intraperitoneal	Baxter Healthcare Corporation	Human Prescription Drug
0941-0415	Dianeal Pd-2 With Dextrose	Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose	Injection, Solution	Intraperitoneal	Baxter Healthcare Corporation	Human Prescription Drug
0941-0424	Dianeal Low Calcium With Dextrose	Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose	Injection, Solution	Intraperitoneal	Baxter Healthcare Corporation	Human Prescription Drug
0941-0426	Dianeal Pd-2 With Dextrose	Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose	Injection, Solution	Intraperitoneal	Baxter Healthcare Corporation	Human Prescription Drug
0941-0427	Dianeal Pd-2 With Dextrose	Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose	Injection, Solution	Intraperitoneal	Baxter Healthcare Corporation	Human Prescription Drug
0941-0429	Dianeal Pd-2 With Dextrose	Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose	Injection, Solution	Intraperitoneal	Baxter Healthcare Corporation	Human Prescription Drug
0941-0430	Dianeal Low Calcium With Dextrose	Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose	Injection, Solution	Intraperitoneal	Baxter Healthcare Corporation	Human Prescription Drug
0941-0433	Dianeal Low Calcium With Dextrose	Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose	Injection, Solution	Intraperitoneal	Baxter Healthcare Corporation	Human Prescription Drug
0941-0457	Dianeal Low Calcium With Dextrose	Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose	Injection, Solution	Intraperitoneal	Baxter Healthcare Corporation	Human Prescription Drug
0941-0459	Dianeal Low Calcium With Dextrose	Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose	Injection, Solution	Intraperitoneal	Baxter Healthcare Corporation	Human Prescription Drug
0941-0484	Dianeal Low Calcium With Dextrose	Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose	Injection, Solution	Intraperitoneal	Baxter Healthcare Corporation	Human Prescription Drug
0941-0487	Dianeal Low Calcium With Dextrose	Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose	Injection, Solution	Intraperitoneal	Baxter Healthcare Corporation	Human Prescription Drug
0941-0490	Dianeal Low Calcium With Dextrose	Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride And Dextrose	Injection, Solution	Intraperitoneal	Baxter Healthcare Corporation	Human Prescription Drug

Field Name	Field Value
Event ID	92931 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1141-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	22,112 bags Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	09-06-2023
Recall Initiation Date	08-11-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Baxter Healthcare Corporation
Code Info	Lot Y406734, Exp 31-Oct-2024 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0941-0411-05; 0941-0411-06; 0941-0411-07; 0941-0411-04; 0941-0411-11; 0941-0413-05; 0941-0413-06; 0941-0413-07; 0941-0413-01; 0941-0413-04; 0941-0415-05; 0941-0415-06; 0941-0415-04; 0941-0415-07; 0941-0415-01; 0941-0409-06; 0941-0409-05; 0941-0409-07; 0941-0409-01; 0941-0457-08; 0941-0457-02; 0941-0457-05; 0941-0457-01; 0941-0459-08; 0941-0459-02; 0941-0459-05; 0941-0459-01; 0941-0426-52; 0941-0426-53; 0941-0426-55; 0941-0427-52; 0941-0427-53; 0941-0427-55; 0941-0429-52; 0941-0429-53; 0941-0429-55; 0941-0424-51; 0941-0424-52; 0941-0424-53; 0941-0424-55; 0941-0430-51; 0941-0430-52; 0941-0430-53; 0941-0430-55; 0941-0433-51; 0941-0433-52; 0941-0433-53; 0941-0433-55; 0941-0484-01; 0941-0487-01; 0941-0490-01
Status	Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.

Field Name	Field Value
Event ID	92931 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1140-2023 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide in the USA What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 44,520; b) 60,762; c) 483,912 Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	09-06-2023
Recall Initiation Date	08-11-2023 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Baxter Healthcare Corporation
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	0941-0411-05; 0941-0411-06; 0941-0411-07; 0941-0411-04; 0941-0411-11; 0941-0413-05; 0941-0413-06; 0941-0413-07; 0941-0413-01; 0941-0413-04; 0941-0415-05; 0941-0415-06; 0941-0415-04; 0941-0415-07; 0941-0415-01; 0941-0409-06; 0941-0409-05; 0941-0409-07; 0941-0409-01; 0941-0457-08; 0941-0457-02; 0941-0457-05; 0941-0457-01; 0941-0459-08; 0941-0459-02; 0941-0459-05; 0941-0459-01; 0941-0426-52; 0941-0426-53; 0941-0426-55; 0941-0427-52; 0941-0427-53; 0941-0427-55; 0941-0429-52; 0941-0429-53; 0941-0429-55; 0941-0424-51; 0941-0424-52; 0941-0424-53; 0941-0424-55; 0941-0430-51; 0941-0430-52; 0941-0430-53; 0941-0430-55; 0941-0433-51; 0941-0433-52; 0941-0433-53; 0941-0433-55; 0941-0484-01; 0941-0487-01; 0941-0490-01
Status	Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.