Official recall record
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 110
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-05-18
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Maquet Medical Systems USA
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2023-11-13 · US FDA — Medical Devices
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 70 - 2023-11-06 · US FDA — Medical Devices
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blo
All 8 official recall notices naming Maquet Medical Systems USA on this site →
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