FDA-Device2023-06-07Class II
HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
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
8,670 (US)
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1634-2023Don't want to check this manually?
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