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Recall Observatory FDA recall evidence

Device product

QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 701067823 BEQ-HMO 71000-USA 701067829

Z-1659-2023

May 18, 2023

Class II

Product summary

Firm
Maquet Medical Systems USA
Event
Event 92006
Status
Ongoing
Classification
Class II
Quantity
0 (US)
Official record key
device-enforcement:Z-1659-2023

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 HMO 70000-USA 701067820 4058863019147 HMO 71000-USA 701067823 4058863017341 BEQ-HMO 71000-USA 701067829 4058863017372 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.