BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI 04058863080383 Lots 3000280906, 3000280907, 3000280908, 3000280909, 3000282253, 3000282254, 3000282255, 3000291127, 3000300688, 3000314506, 3000316206, 3000316600, 3000317531, 3000317532, 3000318850, 3000318851, 3000318852, 3000318853, 3000319748, 3000319749, 3000319750, 3000319751, 3000319778, 3000319781, 3000323082, 3000323084, 3000323085, 3000324495, 3000324496, 3000324497, 3000324499, 3000325557, 3000325558, 3000325559, 3000327120, 3000327121, 3000328404, 3000328405, 3000334413, 3000334414, 3000336487 ***Added 3/21/24*** 3000330091, 3000330092, 3000330094, 3000330095, 3000330096, 3000333095, 3000333096, 3000333097, 3000334409, 3000334410, 3000336488, 3000337834, 3000342904, 3000342905, 3000342906, 3000342907, 3000342908, 3000344446, 3000344447, 3000344471, 3000344472, 3000344474, 3000346048, 3000346049, 3000346050, 3000346051, 3000346052, 3000348543, 3000348546, 3000348552, 3000348553, 3000349793, 3000349795, 3000349796, 3000349797, 3000352614, 3000352615, 3000352616, 3000352617, 3000353439, 3000353440
- 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:
- 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.
- 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 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Product Codes/Lot Numbers:
UDI-DI 04058863080383 Lots 3000280906, 3000280907, 3000280908, 3000280909, 3000282253, 3000282254, 3000282255, 3000291127, 3000300688, 3000314506, 3000316206, 3000316600, 3000317531, 3000317532, 3000318850, 3000318851, 3000318852, 3000318853, 3000319748, 3000319749, 3000319750, 3000319751, 3000319778, 3000319781, 3000323082, 3000323084, 3000323085, 3000324495, 3000324496, 3000324497, 3000324499, 3000325557, 3000325558, 3000325559, 3000327120, 3000327121, 3000328404, 3000328405, 3000334413, 3000334414, 3000336487 ***Added 3/21/24*** 3000330091, 3000330092, 3000330094, 3000330095, 3000330096, 3000333095, 3000333096, 3000333097, 3000334409, 3000334410, 3000336488, 3000337834, 3000342904, 3000342905, 3000342906, 3000342907, 3000342908, 3000344446, 3000344447, 3000344471, 3000344472, 3000344474, 3000346048, 3000346049, 3000346050, 3000346051, 3000346052, 3000348543, 3000348546, 3000348552, 3000348553, 3000349793, 3000349795, 3000349796, 3000349797, 3000352614, 3000352615, 3000352616, 3000352617, 3000353439, 3000353440
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1077-2024
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