Beq-hls 7050 USA recall: Sterility Concern
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as…
Why was Beq-hls 7050 USA recalled?
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
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: 04037691741543 Lots 3000183172, 3000183179, 3000183191, 3000183910, 3000184681
- Product
- BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as…
- Recalling firm
- Maquet Medical Systems USA
- Quantity
- 206 US; 48,960 Worldwide
- Distribution
- Worldwide distribution - US Nationwide and the countries Canada and Australia.
- Recall date
- September 28, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)