FDA-Device2024-02-21Class II
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
Hazard
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.
Sold states
Worldwide - US Nationwide distribution.
Affected count
16520 worldwide; 6657 US
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1076-2024Don't want to check this manually?
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