—#204705

Product

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

FDA product code: CAC — Apparatus, Autotransfusion
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K201305
Affected lot / code info: UDI-DI 00650862115147 Lots 499345 498062 496693 495731 494226 492645 492078 490763 487811 490139 489162 487849 483249 470644 468860 467477 466952

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 #204705. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.