FDA-Device2024-01-24Class I
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Maquet Cardiovascular, LLC
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.
Sold states
Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
Affected count
(34,356 cases/206,136 devices US); (3,902 cases/23,412 devices OUS)
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0709-2024Don't want to check this manually?
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