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Drug FDA Class I Ongoing Foreign material

0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.

B. Braun Medical Inc Published Aug 28, 2024

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact B. Braun Medical Inc or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of Particulate Matter

Hazards

Particulate Matter · primary

Affected products (1)

0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-09.

SODIUM CHLORIDE · 63,444 containers

NDC: 0264-7800, 0264-7800-09
Code info: Lot #: J2L763, J2L764, Exp: 31 March 2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Jul 24, 2024
  2. Published
    Aug 28, 2024
Recall number
D-0638-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.