FDA-Device2023-06-07Class II
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Maquet Medical Systems USA
Hazard
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Sold states
Domestic distribution nationwide.
Affected count
0 (US)
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1640-2023Don't want to check this manually?
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