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Class II: temporary or reversible health riskCompleted

Baxter Healthcare Dianeal PD-2 Peritonial Dialysis Solution Recall

Dianeal PD-2 Peritonial Dialysis Solution with 1

Baxter Healthcare Corporation · Deerfield, IL

Risk level
Class II
Reported by FDA
May 3, 2023
Recall ID
D-0543-2023
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled Dianeal PD-2 Peritonial Dialysis Solution starting Mar 15, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0543-2023 on May 3, 2023. Reason: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Status: Completed.

Why it was recalled

Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.

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.

Lot numbers, UPCs & expiration codes

Lot Y405201, Exp 31-Oct-2024

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0543-2023
Classification
Class II
Status
Completed
Recall initiated
Mar 15, 2023
FDA report date
May 3, 2023
Quantity
9,788 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corporation

Original FDA data

Every field from FDA enforcement report D-0543-2023, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Completed
Country
United States
Event ID
91883
Address
1 Baxter Pkwy
Code information
Lot Y405201, Exp 31-Oct-2024
Postal code
60015-4625
Report date
May 3, 2023
Product type
Drugs
Recall number
D-0543-2023
Classification
Class II
Recalling firm
Baxter Healthcare Corporation
Product quantity
9,788 bags
Reason for recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide in the USA
Recall initiation date
Mar 15, 2023
Initial firm notification
Letter
Center classification date
Apr 24, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0543-2023, published May 3, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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