FDA Device recall Z-0709-2024
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
- FDA Device
- Class I
- ongoing
- Published 2024-01-24
On 2024-01-24 the FDA classified a Class I recall of Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection 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-0709-2024 |
| 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 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
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 00650862115130 Lots 499822 490138 499344 498578 499805 498974 498063 497139 495208 496692 487810 489877 489878…UDI-DI 00650862115130 Lots 499822 490138 499344 498578 499805 498974 498063 497139 495208 496692 487810 489877 489878 496208 496207 496774 495194 495193 494224 493679 492644 492079 490762 490744 487809 489161 485228 483533 487808 485231 486071 485230 483108 485229 483534 475228 475487 483107 483180 477950 474982 474076 474511 472581 473747 474950 474077 474967 469918 469920 471069 471805 471806 469403 470148 468857 469402 469919 467195 468858 468395 468856 467476 467475 466637 466951 467193 467194 466455 467352 466267 466080 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0709-2024%22
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