FDA-Device2023-06-07Class II
QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859
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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