FDA Device recall Z-0710-2024
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
- FDA Device
- Class I
- ongoing
- Published 2024-01-24
On 2024-01-24 the FDA classified a Class I recall of Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit by Maquet Cardiovascular, citing express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infecti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0710-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-12-13 |
| Published | 2024-01-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Maquet Cardiovascular |
| Distribution | US |
Product
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Reason
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.
Identifiers
| code_info | UDI-DI 00650862115147 Lots 499345 498062 496693 495731 494226 492645 492078 490763 487811 490139 489162 487849 483249 470644 468860 467477 466952 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Maquet Cardiovascular
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FDA Device · Class II · 2026-07-22 · Maquet Cardiovascular - Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000
FDA Device · Class II · 2025-10-01 · Maquet Cardiovascular - Heartstring III Proximal Seal System
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular - Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular - Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder
FDA Device · Class II · 2025-09-24 · Maquet Cardiovascular
All Maquet Cardiovascular recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0710-2024%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.