🔍 RecallPedia

AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.

Class I - Dangerous
🏥 Medical Devices Recalled: September 26, 2023 B. Braun Medical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 4046964183454 Lots 0061747706 0061752064 0061755195 0061790409
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
B. Braun Medical, Inc.
Reason for Recall:
Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use.

Product Codes/Lot Numbers:

UDI-DI: 4046964183454 Lots 0061747706 0061752064 0061755195 0061790409

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0130-2024

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