Reported Feb 21, 2024 · Ongoing
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung…
Maquet Medical Systems USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Medical Systems USA · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
- Lot codes and dates
81 of 81 codes
UDI-DI 04058863080383 Lots 30002809063000280907300028090830002809093000282253300028225430002822553000291127300030068830003145063000316206300031660030003175313000317532300031885030003188513000318852300031885330003197483000319749300031975030003197513000319778300031978130003230823000323084300032308530003244953000324496300032449730003244993000325557300032555830003255593000327120300032712130003284043000328405300033441330003344143000336487 ***Added 3/21/24*** 30003300913000330092300033009430003300953000330096300033309530003330963000333097300033440930003344103000336488300033783430003429043000342905300034290630003429073000342908300034444630003444473000344471
- Amount recalled
- 16520 worldwide; 6657 US
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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