The Recall Desk
HighFDA (Devices)·Z-1641-2023·Announced 2023-06-07

QUADROX-i Pediatric Oxygenator Packaging Defects Compromise Sterile Barrier

FDA Class II recall of QUADROX-i Pediatric oxygenators due to packaging defects—creases, holes, cracks—that compromise sterile barriers, risking infection and sepsis during cardiopulmonary bypass procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving documented packaging defects on a critical-use surgical device that compromise sterile barriers. No illnesses or injuries have been reported, but the risk-of-harm potential (infection, sepsis, ischemia) qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Maquet Medical Systems USA is recalling all lots of the QUADROX-i Pediatric oxygenator (models HMO 30000-USA and HMO 31000-USA), a device used during cardiopulmonary bypass procedures in pediatric patients. Two packaging defects have been identified: improper accessory placement during manufacturing may cause creases and damage to the sterile pouch, and packaging may exhibit holes, cracks, dents, or crushed areas.

Both defects compromise the sterile barrier, potentially exposing the device to non-sterile conditions. Use of a compromised device may result in inflammation, infection, sepsis, or ischemia—serious complications during cardiopulmonary bypass procedures. This is an FDA Class II recall affecting devices distributed nationwide in the United States.

The recalled product

Product
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Manufacturer
Maquet Medical Systems USA
Category
Medical Device — Surgical / Cardiopulmonary
Hazard
  • sterile-barrier-compromise
  • contamination
  • infection
  • sepsis
  • ischemia

Distribution

Distributed nationwide across the United States.

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