Device product
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Z-1764-2022
Product summary
- Event
- Event 90740
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 206 US; 48,960 Worldwide
- Official record key
device-enforcement:Z-1764-2022
Official wording
Reason: 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).
Code information: UDI-DI: 04037691741543 Lots 3000183172, 3000183179, 3000183191, 3000183910, 3000184681
Distribution pattern: Worldwide distribution - US Nationwide and the countries Canada and Australia.
Derived failure modes
-
Unknown
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).