Maquet Cardiovascular, LLC: Medical Device Recall in 2024 - (Recall #: Z-0709-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection

Product Classification:

Class I

Date Initiated: December 13, 2023

Date Posted: January 24, 2024

Recall Number: Z-0709-2024

Event ID: 93548

Reason for Recall:

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.

Status: Ongoing

Product Quantity: (34,356 cases/206,136 devices US); (3,902 cases/23,412 devices OUS)

Code Information:

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

Distribution Pattern:

Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK

Voluntary or Mandated:

Voluntary: Firm initiated