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Maquet Cardiovascular, LLC recalls Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Recalled January 24, 2024 · FDA recall Z-0709-2024 · Maquet Cardiovascular
Hazard
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. · FDA Class I
Units
(34,356 cases/206,136 devices US); (3,902 cases/23,412 devices OUS)
Sold at
Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
Description
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.
Product
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Manufacturer(s)
Maquet Cardiovascular, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →