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EXPRESS recallZ-0709-2024 · Maquet Cardiovascular, LLC · initiated Dec 13, 2023

Open, Classified

Is my device affected?

  1. 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.
  2. 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.
  3. 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-0709-2024
Status
Open, Classified
Initiated by the company
Dec 13, 2023
Posted by the FDA
Jan 12, 2024
Recalling firm
Maquet Cardiovascular, LLC
Quantity
(34,356 cases/206,136 devices US); (3,902 cases/23,412 devices OUS)
Product code
CAC
FDA submissions
K043140
Distribution
Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K043140 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93548).

Sources and updates

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