—#204704

Product

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

FDA product code: CAC — Apparatus, Autotransfusion
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K043140
Affected lot / code info: 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

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.

Root cause (FDA determination)

Material/Component Contamination

Action the firm took

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).

Recalling firm

Firm: Maquet Cardiovascular, LLC
Address: 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094

Distribution

Distribution pattern: Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK

Timeline

Recall initiated: 2023-12-13
Posted by FDA: 2024-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204704. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.