Maquet Medical Systems USA 2024-02-21 Health serious FDA
Health · FDA · Recall #FDA-Z-1077-2024
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with… Recall
Issued February 21, 2024 · Maquet Medical Systems USA
In February 2024, Maquet Medical Systems USA recalled the BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
What you should do
- 1 Stop using BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with… 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
- February 21, 2024
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution.
- Recall number
- FDA-Z-1077-2024
- 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 737th Health recall we've logged in 2024.