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Class II: temporary or reversible health riskTerminated

B. Braun Medical Lactated Ringer's Injection Recall

Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B

B. Braun Medical Inc · Irvine, CA

Risk level
Class II
Reported by FDA
Apr 10, 2024
Recall ID
D-0431-2024
Check your lot numberHow we source this data

Summary

B. Braun Medical recalled Lactated Ringer's Injection starting Mar 22, 2024. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0431-2024 on Apr 10, 2024. Reason: Lack of assurance of sterility: bags have the potential to leak.. Status: Terminated.

Why it was recalled

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

Product description

Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00

Lot numbers, UPCs & expiration codes

Lot #: J3N023, Exp: 31 March 2026

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-0431-2024
Classification
Class II
Status
Terminated
Recall initiated
Mar 22, 2024
FDA report date
Apr 10, 2024
Quantity
7,800 bags
Recall type
Voluntary: Firm initiated
Recalling firm
B. Braun Medical Inc

Original FDA data

Every field from FDA enforcement report D-0431-2024, exactly as published.

Show all FDA fields
City
Irvine
State
CA
Status
Terminated
Country
United States
Event ID
94272
Address
2525 Mcgaw Ave
Code information
Lot #: J3N023, Exp: 31 March 2026
Postal code
92614-5841
Report date
Apr 10, 2024
Product type
Drugs
Recall number
D-0431-2024
Classification
Class II
Recalling firm
B. Braun Medical Inc
Product quantity
7,800 bags
Termination date
Jul 1, 2025
Reason for recall
Lack of assurance of sterility: bags have the potential to leak..
Voluntary / mandated
Voluntary: Firm initiated
Product description
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
Distribution pattern
Nationwide in the USA
Recall initiation date
Mar 22, 2024
Initial firm notification
Letter
Center classification date
Apr 3, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0431-2024, published Apr 10, 2024. 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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