Z-1764-2022 Class II Ongoing
FDA device recall Z-1764-2022 was initiated by Maquet Medical Systems USA on Jul 22, 2022 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 206 US; 48,960 Worldwide.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 28, 2022
- Initiation Date
- Jul 22, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 206 US; 48,960 Worldwide
Product Description
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.
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: 04037691741543 Lots 3000183172, 3000183179, 3000183191, 3000183910, 3000184681
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1764-2022
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026