HLS Set Advanced Sterility Breach Recall for Cardiac Support Equipment
Maquet Medical Systems USA is recalling HLS Set Advanced 5050 units due to a potential breach in the sterility barrier. The defect may result in compromised product sterility for this cardiac and respiratory support equipment.
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 sterility breach on a critical medical device used for cardiac and respiratory support. No illnesses or injuries have been reported, but the sterility compromise on life-supporting equipment constitutes a risk-of-harm scenario that warrants a High severity classification.
Plain-English summary
Maquet Medical Systems USA is recalling the BEQ-HLS 5050 USA (HLS Set Advanced 5.0), a preconnected set used for extracorporeal respiratory and cardiovascular support as part of the CARDIOHELP System. The recall affects approximately 6,871 units in the United States and 18,670 units worldwide, distributed to Canada and Australia.
The recall was expanded due to a potential breach in the sterility barrier that may compromise the product's sterility. An initial recall began on November 6, 2020. The affected lot numbers are 3000192081, 3000193363, 3000196200, 3000208697, and 3000216172.
Equipment users should check whether their device lot number is among those affected.
The recalled product
- Product
- 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.
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterility-breach
- infection-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 (5)
- UDI-DI: 04058863076355 Lots 3000192081
- 3000193363
- 3000196200
- 3000208697
- 3000216172
Distribution
Distributed nationwide across the United States.
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