FDA Device recall Z-1638-2023
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no
- FDA Device
- Class II
- ongoing
- Published 2023-06-07
On 2023-06-07 the FDA classified a Class II recall of QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no by Maquet Medical Systems Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1638-2023 |
| 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 Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA 701067823
Reason
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.
Identifiers
| code_info | Model Item no. UDI-DI HMO 70000-USA 701067820 4058863019147 HMO 71000-USA…Model Item no. UDI-DI HMO 70000-USA 701067820 4058863019147 HMO 71000-USA 701067823 4058863017341 All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1638-2023%22
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