FDA Enforcement
Class I
Ongoing
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Recall: Z-0710-2024
·
Reported January 24, 2024
Enforcement
- Recall Number
- Z-0710-2024
- Event ID
- 93548
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Maquet Cardiovascular, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 24, 2024
- Initiation Date
- December 13, 2023
- Classification Date
- January 12, 2024
- Address
- 45 Barbour Pond Dr, N/A, Wayne, NJ, 07470-2094, United States
Description
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Reason
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.
Code Info
UDI-DI 00650862115147 Lots 499345 498062 496693 495731 494226 492645 492078 490763 487811 490139 489162 487849 483249 470644 468860 467477 466952
Distribution
Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
Quantity
(7,501 cases/45,006 devices US); no OUS