Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
FDA Recall #Z-0710-2024 — Class I — December 13, 2023
Product Description
Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
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.
Recalling Firm
Maquet Cardiovascular, LLC — Wayne, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
(7,501 cases/45,006 devices US); no OUS
Distribution
Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK
Code Information
UDI-DI 00650862115147 Lots 499345 498062 496693 495731 494226 492645 492078 490763 487811 490139 489162 487849 483249 470644 468860 467477 466952
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated