FDA Device recall Z-1660-2023
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416
- FDA Device
- Class II
- ongoing
- Published 2023-06-07
On 2023-06-07 the FDA classified a Class II recall of QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416 by Maquet Medical Systems Usa, citing 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 res….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1660-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-18 |
| Published | 2023-06-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Maquet Medical Systems Usa |
| Distribution | US |
Product
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Reason
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.
Identifiers
| code_info | Model Item No. UDI HMO 10000-USA 701070412 40…Model Item No. UDI HMO 10000-USA 701070412 4058863154473 HMO 11000-USA 701070416 4058863154558 All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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FDA Device · Class II · 2024-05-22 · Maquet Medical Systems Usa - Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077
FDA Device · Class II · 2024-02-21 · Maquet Medical Systems Usa - BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078
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FDA Device · Class II · 2024-02-14 · Maquet Medical Systems Usa
All Maquet Medical Systems Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1660-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.