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Recall Observatory FDA recall evidence

Device product

BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859

Z-1635-2023

May 18, 2023

Class II

Product summary

Firm
Maquet Medical Systems USA
Event
Event 92003
Status
Ongoing
Classification
Class II
Quantity
15,880 (US)
Official record key
device-enforcement:Z-1635-2023

Official wording

Reason: 1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

Code information: UDI-DI: 04058863019024 All lots

Distribution pattern: Domestic distribution nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.