Medical device set recalled for potential sterility barrier compromise
Maquet Medical Systems USA is recalling the BEQ-HLS 5050 (HLS Set Advanced 5.0) due to a potential breach in the sterility barrier that may compromise product sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a critical medical device component used in life-support applications. The hazard is a potential sterility barrier breach with no reported illnesses or injuries, meeting the criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Maquet Medical Systems USA is recalling the BEQ-HLS 5050 USA, model 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. The recall is due to a potential breach in the sterility barrier that may result in compromised product sterility.
Approximately 206 units were distributed in the United States, with 48,960 units distributed worldwide including Canada and Australia. The affected lot is 3000183908. This recall expands an earlier recall initiated on November 6, 2020, regarding the same sterility concern.
The recalled product
- Product
- 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.
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterility-barrier-breach
- product-contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04037691773513 Lot 3000183908
Distribution
Distributed nationwide across the United States.
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