Quadrox-ir recall: Sterility Concern
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE coating…
Why was Quadrox-ir recalled?
Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.
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?
Model Item No. UDI-DI BEQ-HMO 51100-USA 701067936 N/A BEQ-HMO 71100-USA 701067880 4058863164052 HMO 50100-USA 701067934 N/A HMO 51100-USA 701067938 N/A HMO 70100-USA 701067874 N/A HMO 71100-USA 701067886 N/A All lots
- Product
- QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE coating…
- Recalling firm
- Maquet Medical Systems USA
- Quantity
- 0 (US)
- Distribution
- Nationwide domestic distribution
- Recall date
- June 7, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)