FDA-Device2023-06-07Class II
QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859
Maquet Medical Systems USA
Hazard
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.
Sold states
Nationwide domestic distribution
Affected count
24,250 (US)
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1656-2023Don't want to check this manually?
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