Z-0709-2024Class I

Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection

Name: Z-0709-2024 Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
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 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection 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-0709-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-12-13
Posted: 2024-01-12
Recalling firm: Maquet Cardiovascular LLC
Product: Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
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: (34,356 cases/206,136 devices US); (3,902 cases/23,412 devices 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 00650862115130 Lots 499822 490138 499344 498578 499805 498974 498063 497139 495208 496692 487810 489877 489878 496208 496207 496774 495194 495193 494224 493679 492644 492079 490762 490744 487809 489161 485228 483533 487808 485231 486071 485230 483108 485229 483534 475228 475487 483107 483180 477950 474982 474076 474511 472581 473747 474950 474077 474967 469918 469920 471069 471805 471806 469403 470148 468857 469402 469919 467195 468858 468395 468856 467476 467475 466637 466951 467193 467194 466455 467352 466267 466080

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0709-2024
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

K043140Class IIExpress and Oasis Chest DrainAtrium Medical Corp. / cleared 2004-12-08

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)