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Recall Observatory FDA recall evidence

Device product

Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit

Z-0710-2024

December 13, 2023

Class I

Product summary

Firm
Maquet Cardiovascular, LLC
Event
Event 93548
Status
Ongoing
Classification
Class I
Quantity
(7,501 cases/45,006 devices US); no OUS
Official record key
device-enforcement:Z-0710-2024

Official wording

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 information: UDI-DI 00650862115147 Lots 499345 498062 496693 495731 494226 492645 492078 490763 487811 490139 489162 487849 483249 470644 468860 467477 466952

Distribution pattern: Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.