ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI: 4046964823749 Lot 0061745499, 0061745500, 0061745501, 0061792770
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation.
Product Codes/Lot Numbers:
UDI-DI: 4046964823749 Lot 0061745499, 0061745500, 0061745501, 0061792770
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0134-2024
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