Recall archive / FDA device enforcement
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection — FDA record Z-0709-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 13, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class I
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- (34,356 cases/206,136 devices US); (3,902 cases/23,412 devices OUS)
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0709-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jan 24, 2024
- Recall initiation date
- Dec 13, 2023
- Center classification date
- Jan 12, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.