Z-0710-2024Class I

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

Name: Z-0710-2024 Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Creator: Maquet Cardiovascular, LLC
Published: 2023-12-13
License: https://open.fda.gov/license/

Maquet Cardiovascular LLC / initiated 2023-12-13 / Open, Classified / root cause: manufacturing process

FDA source

Maquet Cardiovascular, LLC began a recall of Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit on 2023-12-13. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0710-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-12-13
Posted: 2024-01-12
Recalling firm: Maquet Cardiovascular LLC
Product: Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Product code: CAC Apparatus, Autotransfusion
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: 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).
Quantity in commerce: (7,501 cases/45,006 devices US); no OUS
Distribution: Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
Product codes and lots: UDI-DI 00650862115147 Lots 499345 498062 496693 495731 494226 492645 492078 490763 487811 490139 489162 487849 483249 470644 468860 467477 466952

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0710-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0709-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12
Z-0710-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-12

Product code CAC

K201305Class IIAuto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest DrainAtrium Medical Corporation / cleared 2021-09-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)