Z-1765-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 28, 2022
- Initiation Date
- July 22, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 206 US; 48,960 Worldwide
Product Description
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
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 Pattern
Worldwide distribution - US Nationwide and the countries Canada and Australia.
Code Information
UDI-DI: 04037691773513 Lot 3000183908