Medical Device Recall: Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
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
(7,501 cases/45,006 devices US); no OUS
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0710-2024
Status: ongoing
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