Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot 19-03466
- 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:
- Maquet Cardiovascular Us Sales, Llc
- Reason for Recall:
- A lot of Avalon Elite Vascular Access Kits (VAK) are being recalled due to a material mix-up with the needle portion of the kit; 81 of 255 kits were assembled with an incorrect Arterial Access Needle instead of a Multi-Purpose Procedure Needle.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039
Product Codes/Lot Numbers:
Lot 19-03466
Distribution:
Distributed in: AL, AZ, CA, CT, FL, GA, IL, MA, MI, NC, NH, NM, NY, OH, OK, TN, TX, VA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1603-2020
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