Skip to content
Recall Observatory FDA recall evidence

Device product

QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895

Z-1657-2023

May 18, 2023

Class II

Product summary

Firm
Maquet Medical Systems USA
Event
Event 92006
Status
Ongoing
Classification
Class II
Quantity
1,784 (US)
Official record key
device-enforcement:Z-1657-2023

Official wording

Reason: Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

Code information: Model Item no. UDI-DI BEQ-HMO 50000-USA 701067905 4058863019079 HMO 50000-USA 701067891 4058863019055 HMO 51000-USA 701067895 4058863019185 All lots

Distribution pattern: Nationwide domestic distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.