Model No. BEQ-HLS 5050 USA recall: Sterility Concern
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Why was Model No. BEQ-HLS 5050 USA 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 04058863076355 Lots 3000301222, 3000319782, 3000327602 ***Added 3/21/24*** 3000333098, 3000352360, 3000357174
- Product
- Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
- Recalling firm
- Maquet Medical Systems USA
- Quantity
- 16520 worldwide; 6657 US
- Distribution
- Worldwide - US Nationwide distribution.
- Recall date
- February 21, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)