Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
QUADROX-i Pediatric Recalled by Maquet Medical Systems USA Due to Product packaging may exhibit small pinholes which may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Maquet Medical Systems USA directly.
Affected Products
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Quantity: 0 (US)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Maquet Medical Systems USA
Maquet Medical Systems USA has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report