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.
Check against the official notice below — it lists the full affected range.
Maquet Medical Systems USA is expanding a recall for the BEQ-HLS 5050 HLS Set Advanced 5.0, a preconnected set used for extracorporeal respiratory and/or cardiovascular support as part of the CARDIOHELP system. The expanded recall addresses a potential breach in the sterility barrier that may result in compromised product sterility. The product was distributed nationwide in the US as well as in Canada and Australia, with 6,871 units affected in the US and 18,670 worldwide.
The affected lots are: 3000192081, 3000193363, 3000196200, 3000208697, and 3000216172 (UDI-DI: 04058863076355). This is an expansion of a recall originally initiated on November 6, 2020. The source document does not specify what remedy or action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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).
Reason for recall: 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). Distribution: Worldwide distribution - US Nationwide and the countries Canada and Australia. Quantity: 6,871 US; 18,670 worldwide Lot/code info: UDI-DI: 04058863076355 Lots 3000192081, 3000193363, 3000196200, 3000208697, 3000216172
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.