The FDA announced on Dec. 13, 2023, that Maquet Cardiovascular, LLC is recalling the Express BRU W/AC Blood Recovery Unit because it may be pre-packaged with sterile water syringes subject to a separate recall, potentially exposing patients to infectious material. The agency classified this Class I recall as voluntary and firm-initiated.
How to tell if you have it
- Brand: Maquet
- Product: REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
- UDI-DI: 00650862115147
- Lots: 499345, 498062, 496693, 495731, 494226, 492645, 492078, 490763, 487811, 490139, 489162, 487849, 483249, 470644, 468860, 467477, 466952
The hazard
The hazard arises because the Express chest drains are pre-packaged with sterile water syringes that have been 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.
Context
GovInfoNow's records show Maquet Cardiovascular, LLC has 25 other recalls on record since Jan. 24, 2019. Other recent recalls of similar products include Medline Reprocessed Catheters Recall (May 15, 2026), Embosphere 500-700 Micrometer Syringe Recall (Aug. 10, 2026), and Medline Blood Culture Kits Recall (June 12, 2026).