Medtronic Perfusion Systems 2023-02-08 Health serious FDA
Health · FDA · Recall #FDA-Z-1028-2023
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated… Recall
Issued February 8, 2023 · Medtronic Perfusion Systems
In February 2023, Medtronic Perfusion Systems recalled the Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion circuit.
What you should do
- 1 Stop using Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Medtronic Perfusion Systems 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
- Medtronic Perfusion Systems
- Category
- Health
- Recall date
- February 8, 2023
- Units affected
- Not reported
- Sold at
- Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia
- Recall number
- FDA-Z-1028-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Medtronic Perfusion Systems has 11 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.