Maquet Medical Systems USA 2023-06-07 Health serious FDA
Health · FDA · Recall #FDA-Z-1657-2023
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model … Recall
Issued June 7, 2023 · Maquet Medical Systems USA
In June 2023, Maquet Medical Systems USA recalled the QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Maquet Medical Systems USA to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Maquet Medical Systems USA
- Category
- Health
- Recall date
- June 7, 2023
- Units affected
- Not reported
- Sold at
- Nationwide domestic distribution
- Recall number
- FDA-Z-1657-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Maquet Medical Systems USA has 5 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.