FDA-Device2022-09-28Class II
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Maquet Medical Systems USA
Hazard
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).
Sold states
Worldwide distribution - US Nationwide and the countries Canada and Australia.
Affected count
6,871 US; 18,670 worldwide
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1766-2022Don't want to check this manually?
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