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Recall Observatory FDA recall evidence

Device product

QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388

Z-1641-2023

May 18, 2023

Class II

Product summary

Firm
Maquet Medical Systems USA
Event
Event 92003
Status
Ongoing
Classification
Class II
Quantity
0 (US)
Official record key
device-enforcement:Z-1641-2023

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: Model Item No. UDI-DI HMO 30000-USA 701070384 4058863153681 HMO 31000-USA 701070388 4058863154299 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.