Cardiopulmonary bypass oxygenator recalled due to sterile barrier packaging defects
Maquet Medical Systems USA is recalling 8,670 HMOD 70000-USA/QUADROX-iD Adult oxygenators used in cardiopulmonary bypass due to packaging defects that may compromise sterile barriers and expose devices to contamination.
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: This is a Class II medical device recall affecting devices used in critical cardiac procedures. While no illnesses or injuries have been reported, the recall addresses a risk-of-harm situation where sterile barrier compromise could lead to infection or sepsis. Per the rubric, risk-of-harm products where injury has not yet been reported score 3 (High).
Plain-English summary
Maquet Medical Systems USA is recalling approximately 8,670 HMOD 70000-USA/QUADROX-iD Adult oxygenators (Item no. 701067840) used in cardiopulmonary bypass procedures. The devices were distributed nationwide in the United States and include all manufacturing lots (UDI-DI: 04058863019000).
An accessory may be improperly placed during packaging, causing creases and damage to the sterile pouch. Additionally, product packaging may exhibit holes, cracks, dents, and crushed areas. Both defects can compromise the sterile barrier, potentially exposing the device to non-sterile conditions.
Exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia. Healthcare facilities that received this device should verify their inventory and contact Maquet Medical Systems USA for further guidance on replacement or return.
The recalled product
- Product
- HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
- 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: 04058863019000 All lots
Distribution
Distributed nationwide across the United States.
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