Reported Dec 23, 2020 · Terminated
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product…
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 Name
BEQ-HLS 5050 USAHLS Set Advanced 5.0
- Product Code/Part Number70105.2797 -
- 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 5050
- Part Number70105.2797
- UDI Code04037691773513
- Lot Codes
127 of 127 codes
701277907012779170127792701277937012792170127922701279237012792470128195701281967012819770128328701283297012833070128331701292427012924370129244701292457012938070129381701293827012938370129469701294707012947170129472701295567012955770129558701295597012963470129635701296377012963870129849701298507013007170130072701302077013020870130209701308837013088470130885701308867013109070131091701310927013109370131159701311607013116170131162701314057013140670131407701314087013147470131475
- Amount recalled
- 58,438 devices worldwide
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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