Oxygenator devices recalled due to packaging damage compromising sterile barrier
Maquet Medical Systems USA recalls 15,880 QUADROX-iD oxygenators nationwide due to packaging damage that may compromise sterile barriers, potentially exposing patients to infection.
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 of a critical surgical device with potential for serious infection and sepsis if sterile barrier is compromised, but no reported illnesses or injuries to date. The hazard is theoretical rather than proven.
Plain-English summary
This recall affects the BEQ-HMOD70000-USA/QUADROX-iD oxygenator, a device used during cardiopulmonary bypass (heart-lung) procedures. Approximately 15,880 units have been distributed nationwide in the United States.
The recall is due to two packaging-related issues. First, accessories may be improperly placed during packaging, causing creases and damage to the sterile pouch. Second, product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues can compromise the sterile barrier that protects the device from contamination.
If the sterile barrier is compromised, non-sterile material may contaminate the product. This could expose patients to inflammation, infection, sepsis, and ischemia during or after cardiac surgery. No illnesses or injuries have been reported to date.
Affected devices are identified by UDI-DI: 04058863019024 for all lots. Healthcare providers should verify their inventory and contact Maquet Medical Systems USA if they have potentially affected units.
The recalled product
- Product
- BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- sterile-barrier-compromise
- infection
- sepsis
- ischemia
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: 04058863019024 All lots
Distribution
Distributed nationwide across the United States.
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