Venous Hardshell Cardiotomy Reservoirs recalled for sterile packaging defects
Maquet Medical Systems USA is recalling Venous Hardshell Cardiotomy Reservoirs for cardiopulmonary bypass due to sterile packaging defects. Exposure to non-sterile product could result in infection, sepsis, or ischemia.
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 medical device for cardiac surgery with potential for serious complications (sepsis, ischemia), but no illnesses or injuries reported in the source. Classified as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Maquet Medical Systems USA is recalling Venous Hardshell Cardiotomy Reservoirs, Models VKMO 10000-USA and VKMO 11000-USA. These devices are used during cardiopulmonary bypass procedures.
The recalled devices have manufacturing and packaging defects. 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 issues compromise the sterile barrier of the packaging.
If the sterile barrier is compromised, the product may be exposed to non-sterile conditions. This exposure could result in inflammation, infection, sepsis, and ischemia.
The affected devices were distributed nationwide. All lots of the recalled models are included in this recall.
The recalled product
- Product
- Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA 701070445
- Manufacturer
- Maquet Medical Systems USA
- Hazard
- contamination
- infection
- sepsis
- ischemia
Distribution
Distributed nationwide across the United States.
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