Recall Enforment Report D-0351-2019

Recall Details

Drug Recall Enforcement Report Class II voluntary initiated by Baxter Healthcare Corporation, originally initiated on 01-02-2019 for the product 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. The product was recalled due to lack of assurance of sterility: confirmed customer complaints for leaks on the tubing.. The product was distributed nationwide and the recall is currently terminated.

Field Name Field Value
Event ID 81881 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0351-2019 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 to Wholesaler/Distributors, Healthcare Facilities and Home Patients. 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 with 1.5% Dextrose, 2000 mL UltraBag container bag, Rx only; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code 5B9766, NDC 0941-0424-52.
Reason For Recall Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing. What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 29,370 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 01-16-2019
Recall Initiation Date 01-02-2019 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Termination Date 04-29-2020 What is the Date Terminated?
The date that FDA terminated 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 #: Y281477, Expiry: 02/2020 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 Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products

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