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

FDA device recall Z-0709-2024 · posted 2024-01-12 · Open, Classified

Recall details

Recalling firm

Maquet Cardiovascular, LLC

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.

Action taken

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).

Root cause

Material/Component Contamination

Status

Open, Classified

Product code

CAC

Quantity affected

(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

Date initiated

2023-12-13

Date posted

2024-01-12

Location

Wayne, NJ

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