FDA-Device2024-01-24Class I
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
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
(7,501 cases/45,006 devices US); no OUS
Manufactured in
45 Barbour Pond Dr, N/A, Wayne, NJ, United States
Products
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0710-2024Don't want to check this manually?
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