EXPRESS recallZ-0710-2024 · Maquet Cardiovascular, LLC · initiated Dec 13, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Maquet Cardiovascular, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Material/Component Contamination
What the company is doing
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).
Recall details
- Recall number
- Z-0710-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 13, 2023
- Posted by the FDA
- Jan 12, 2024
- Recalling firm
- Maquet Cardiovascular, LLC
- Quantity
- (7,501 cases/45,006 devices US); no OUS
- Product code
- CAC
- FDA submissions
- K201305
- Distribution
- Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
Product description
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Code information (models, lots, serial numbers)
UDI-DI 00650862115147 Lots 499345 498062 496693 495731 494226 492645 492078 490763 487811 490139 489162 487849 483249 470644 468860 467477 466952
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EXPRESS 4050-100NAtrium Medical Corporation · APPARATUS, AUTOTRANSFUSION2 recalls2 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93548).
- Z-0709-2024 · Open, ClassifiedProduct REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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