Reported Dec 23, 2020 · Terminated
HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage:…
Maquet Cardiovascular US Sales, LLC
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 Cardiovascular Us Sales, Llc · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- HLS Set Advanced
- Model
BEQ-HLS 7050 USAHLS Set Advanced 7.0
- Product Code/Part Number70105.2794 -
- Product UsageThese devices are used with the CARDIOHELP system in order to provide extracorporeal circulation for cardiac support and/or pulmonary support
- Lot codes and dates
- Model NumberBEQ-HLS 7050
- Part Number70105.2794
- UDI Code04037691773513
- Lot Codes
701303647013226970133476701335927013362370133624701336257013479070135038
- Amount recalled
- N/A
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 HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product's sterility barrier.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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