Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
FDA Recall #Z-0709-2024 — Class I — December 13, 2023
Product Description
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.
Recalling Firm
Maquet Cardiovascular, LLC — Wayne, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
(34,356 cases/206,136 devices US); (3,902 cases/23,412 devices 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 00650862115130 Lots 499822 490138 499344 498578 499805 498974 498063 497139 495208 496692 487810 489877 489878 496208 496207 496774 495194 495193 494224 493679 492644 492079 490762 490744 487809 489161 485228 483533 487808 485231 486071 485230 483108 485229 483534 475228 475487 483107 483180 477950 474982 474076 474511 472581 473747 474950 474077 474967 469918 469920 471069 471805 471806 469403 470148 468857 469402 469919 467195 468858 468395 468856 467476 467475 466637 466951 467193 467194 466455 467352 466267 466080
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated