Skip to content
Recall Observatory FDA recall evidence

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

July 22, 2022

Class II

Product summary

Firm
Maquet Medical Systems USA
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

    reason.no_named_rule · v1.0.0

    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).