Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Recall
- Recall Number
- Z-0710-2024
- Event Number
- 93548
- Firm
- Maquet Cardiovascular, LLC
- FEI Number
- 2242352
- Product Code
- CAC
- Status
- Open, Classified
- Root Cause
- Material/Component Contamination
- Initiated
- December 13, 2023
- Posted
- January 12, 2024
- Address
- 45 Barbour Pond Dr, Wayne, NJ, 07470-2094
Description
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
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.
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).
Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
(7,501 cases/45,006 devices US); no OUS