FDA recall Z-0709-2024

Maquet Cardiovascular, LLC · Class I · device

Product

Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection

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

Key facts

Status
Ongoing
Initiation date
2023-12-13
Report date
2024-01-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0709-2024