Medical Device Recall: CARDIOHELP HLS Set Advanced Sterility Barrier Breach
Maquet Medical Systems is expanding its recall of the CARDIOHELP HLS Set Advanced due to a potential breach in the sterility barrier that could compromise product sterility, affecting 6,871 US units and 18,670 worldwide.
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 without reported hospitalizations, illnesses, or injuries. The hazard is a potential sterility breach with theoretical contamination risk. No actual product failures or patient harm have been reported, placing this within the High severity category for risk-of-harm medical devices where injury has not yet been reported.
Plain-English summary
Maquet Medical Systems USA is expanding its recall of the BEQ-HLS 7050 USA (HLS Set Advanced 7.0, Part No. 70106.9078), a preconnected set used for extracorporeal respiratory and/or cardiovascular support as part of the CARDIOHELP System.
The recall was expanded due to a potential breach in the sterility barrier that may compromise product sterility. The original recall was initiated on November 6, 2020.
The expanded recall affects 6,871 units distributed in the United States and 18,670 units distributed worldwide, including Canada and Australia. Specific lot numbers are identified in the FDA recall documentation.
The recalled product
- Product
- BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterility-breach
- contamination
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 (20)
- UDI-DI: 04058863080383 Lots 3000190535
- 3000190536
- 3000190537
- 3000192076
- 3000192077
- 3000192078
- 3000192079
- 3000193358
- 3000193359
- 3000193360
- 3000193361
- 3000193362
- 3000195061
- 3000195062
- 3000195063
- 3000195064
- 3000195065
- 3000195066
- 3000195067
- 3000196193
Distribution
Distributed nationwide across the United States.
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