FDA Device recall Z-1641-2023
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
- FDA Device
- Class II
- ongoing
- Published 2023-06-07
On 2023-06-07 the FDA classified a Class II recall of QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388 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-1641-2023 |
| 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 Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
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 30000-USA 701070384 4058863153681 HMO 31000-USA…Model Item No. UDI-DI HMO 30000-USA 701070384 4058863153681 HMO 31000-USA 701070388 4058863154299 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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All Maquet Medical Systems Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1641-2023%22
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