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.
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).
Worldwide distribution - US Nationwide and the countries Canada and Australia.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1766-2022