BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.
Class I - DangerousWhat Should You Do?
- Check if you have this product: HLS Set Advanced 5.0, Product Code 70106.9077 UDI-DI 04058863076355 HLS Set Advanced 7.0, Product Code 70106.9078 UDI-DI 04058863080383 All lots/batches affected
- 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 Medical Systems USA
- Reason for Recall:
- Firm has initiated a removal of the product due to insufficient evidence of packaging sterility. Exposure to a non-sterile medical device may result in inflammation, infection, sepsis, or ischemia.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extracorporeal respiratory and/or cardiovascular support.
Product Codes/Lot Numbers:
HLS Set Advanced 5.0, Product Code 70106.9077 UDI-DI 04058863076355 HLS Set Advanced 7.0, Product Code 70106.9078 UDI-DI 04058863080383 All lots/batches affected
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1188-2023
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The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Maquet Medical Systems USA
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.