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Class II: temporary or reversible health riskTerminated

B. Braun Medical 0.9% Sodium Chloride Injection 1000 mL Recall

0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-…

B. Braun Medical, Inc. · Allentown, PA

Risk level
Class II
Reported by FDA
Dec 14, 2022
Recall ID
D-0076-2023
Check your lot numberHow we source this data

Summary

B. Braun Medical recalled 0.9% Sodium Chloride Injection 1000 mL starting Nov 25, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0076-2023 on Dec 14, 2022. Reason: Lack of sterility assurance: Bags have the potential to leak. Status: Terminated.

Why it was recalled

Lack of sterility assurance: Bags have the potential to leak.

Product description

0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862

Lot numbers, UPCs & expiration codes

Lot: 0061832446 Exp. 31 Oct 2024

Where it was sold

FL, NJ, PA

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-0076-2023
Classification
Class II
Status
Terminated
Recall initiated
Nov 25, 2022
FDA report date
Dec 14, 2022
Quantity
756 bags
Recall type
Voluntary: Firm initiated
Recalling firm
B. Braun Medical, Inc.

Original FDA data

Every field from FDA enforcement report D-0076-2023, exactly as published.

Show all FDA fields
City
Allentown
State
PA
Status
Terminated
Country
United States
Event ID
91194
Address
901 Marcon Blvd
Code information
Lot: 0061832446 Exp. 31 Oct 2024
Postal code
18109-9512
Report date
Dec 14, 2022
Product type
Drugs
Recall number
D-0076-2023
Classification
Class II
Recalling firm
B. Braun Medical, Inc.
Product quantity
756 bags
Termination date
Aug 23, 2024
Reason for recall
Lack of sterility assurance: Bags have the potential to leak.
Voluntary / mandated
Voluntary: Firm initiated
Product description
0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862
Distribution pattern
FL, NJ, PA
Recall initiation date
Nov 25, 2022
Initial firm notification
Letter
Center classification date
Dec 5, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0076-2023, published Dec 14, 2022. 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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