Maquet Cardiovascular, LLC: Medical Device Recall in 2024 - (Recall #: Z-0710-2024)

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 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit

Product Classification:

Class I

Date Initiated: December 13, 2023

Date Posted: January 24, 2024

Recall Number: Z-0710-2024

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: (7,501 cases/45,006 devices US); no OUS

Code Information:

UDI-DI 00650862115147 Lots 499345 498062 496693 495731 494226 492645 492078 490763 487811 490139 489162 487849 483249 470644 468860 467477 466952

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