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Class II: temporary or reversible health riskTerminated

Baxter Healthcare 0.9% Sodium Chloride Irrigation 5000 mL bags Recall

0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporati…

Baxter Healthcare Corporation · Deerfield, IL

Risk level
Class II
Reported by FDA
Nov 27, 2019
Recall ID
D-0517-2020
Check your lot numberHow we source this data

Summary

Baxter Healthcare recalled 0.9% Sodium Chloride Irrigation 5000 mL bags starting Nov 19, 2019. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0517-2020 on Nov 27, 2019. Reason: Lack of Assurance of Sterility: Product has the potential to leak. Status: Terminated.

Why it was recalled

Lack of Assurance of Sterility: Product has the potential to leak.

Product description

0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29

Lot numbers, UPCs & expiration codes

Lot #: Y309971, Y309971A, Exp. date 6/30/2021

Where it was sold

Nationwide within the United States

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-0517-2020
Classification
Class II
Status
Terminated
Recall initiated
Nov 19, 2019
FDA report date
Nov 27, 2019
Quantity
22336 bags
Recall type
Voluntary: Firm initiated
Recalling firm
Baxter Healthcare Corporation

Original FDA data

Every field from FDA enforcement report D-0517-2020, exactly as published.

Show all FDA fields
City
Deerfield
State
IL
Status
Terminated
Country
United States
Event ID
84288
Address
1 Baxter Pkwy
Code information
Lot #: Y309971, Y309971A, Exp. date 6/30/2021
Postal code
60015-4625
Report date
Nov 27, 2019
Product type
Drugs
Recall number
D-0517-2020
Classification
Class II
Recalling firm
Baxter Healthcare Corporation
Product quantity
22336 bags
Termination date
Feb 4, 2021
Reason for recall
Lack of Assurance of Sterility: Product has the potential to leak.
Voluntary / mandated
Voluntary: Firm initiated
Product description
0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015, NDC 0338-0047-29
Distribution pattern
Nationwide within the United States
Recall initiation date
Nov 19, 2019
Initial firm notification
Letter
Center classification date
Nov 20, 2019

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0517-2020, published Nov 27, 2019. View the source record (openFDA) · FDA enforcement reports

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

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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