Maquet Cardiovascular, LLC Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Brand
Maquet Cardiovascular, LLC
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI 00650862115147 Lots 499345 498062 496693 495731 494226 492645 492078 490763 487811 490139 489162 487849 483249 470644 468860 467477 466952
Maquet Cardiovascular, LLC is recalling Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit due to 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 pati. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On December 13, 2023, the firm notified customers through "URGENT MEDICAL DEVICE CORRECTION" letters. Customers were instructed to examine their inventory to determine if they had any affected lots of the Atrium Express Dry Suction Dry Seal Chest Drains. The correction only affects the sterile water syringe; do not use this syringe. If customers do not need visualization of active pneumothorax, they may keep the affected Express chest drain and set up without water. If customers wish to use the Express chest drain as intended, they may replace the affected sterile water syringe with a new syringe filled with sterile water using aseptic technique. Customers also have the option of returning affected Express chest drains to the firm for credit. If you have any questions, please contact your Getinge representative or call the Getinge Customer Support at (888) 943-8872 (press option 2), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m.(Eastern Time Zone).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026