FDA-Device2023-06-07Class II
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
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
15,880 (US)
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1635-2023Don't want to check this manually?
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