Device product
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.
Z-1766-2022
Product summary
- Event
- Event 90740
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6,871 US; 18,670 worldwide
- Official record key
device-enforcement:Z-1766-2022
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: 04058863076355 Lots 3000192081, 3000193363, 3000196200, 3000208697, 3000216172
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).