Maquet QUADROX-i Adult Oxygenator recalled for packaging damage compromising sterile barrier
Maquet Medical Systems is recalling QUADROX-i Adult Oxygenators due to potential packaging damage that may compromise sterile barriers, risking infection during cardiopulmonary bypass surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II recall of a critical surgical device. Although no illnesses have been reported, the packaging defects compromise the sterile barrier during cardiopulmonary bypass, creating significant risk of infection, sepsis, and ischemia.
Plain-English summary
Maquet Medical Systems USA is recalling the BEQ-HMO 71000-USA / QUADROX-i Adult Oxygenator, a medical device used during cardiopulmonary bypass procedures. The recall affects all lots nationwide.
The company identified two packaging defects: an accessory may be improperly placed during manufacturing, causing creases and damage to the sterile pouch; additionally, the product packaging may exhibit holes, cracks, dents, and crushed areas. Both defects compromise the sterile barrier of the packaging.
When the sterile barrier is compromised, non-sterile product may be exposed, creating risk of inflammation, infection, sepsis, and ischemia in patients undergoing cardiac surgery. If you or a family member is scheduled for or has recently undergone cardiopulmonary bypass surgery with this device, contact your healthcare provider or Maquet Medical Systems USA immediately for guidance.
The recalled product
- Product
- BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
- Manufacturer
- Maquet Medical Systems USA
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 4058863017372 All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Maquet Medical Systems USA under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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