Medical Device Recall: Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Maquet Cardiovascular, LLC · December 13, 2023
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.
Distribution
Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
States Affected
NATIONWIDE
Quantity Affected
(34,356 cases/206,136 devices US); (3,902 cases/23,412 devices OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0709-2024
Status: ongoing
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