Reported Sep 28, 2022 · Ongoing
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory…
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 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
- Lot codes and dates
- UDI-DI
81 of 81 codes
04058863080383 Lots 300019053530001905363000190537300019207630001920773000192078300019207930001933583000193359300019336030001933613000193362300019506130001950623000195063300019506430001950653000195066300019506730001961933000196195300019619630001961973000196198300019619930001978303000197831300019783330001978373000197839300019906930001990713000199072300019907330001990743000199077300020010830002001103000200111300020011230002001133000202025300020202730002020293000202030300020203130002030923000203093300020405830002041563000204157300020428430002058783000205879300020588030002075103000208687300020869230002106293000210630
- UDI-DI
- Amount recalled
- 6,871 US; 18,670 worldwide
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
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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