Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Reported: February 21, 2024 Initiated: January 16, 2024 #Z-1076-2024
Product Description
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Reason for Recall
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Details
- Recalling Firm
- Maquet Medical Systems USA
- Units Affected
- 16520 worldwide; 6657 US
- Distribution
- Worldwide - US Nationwide distribution.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.. Recalled by Maquet Medical Systems USA. Units affected: 16520 worldwide; 6657 US.
Why was this product recalled? ▼
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 21, 2024. Severity: Moderate. Recall number: Z-1076-2024.
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