Recall · FDA
Alcon Research, LTD.
Alcon Research, LTD. issued a Class II FDA recall (Z-2408-2023) initiated 2023-06-28: Infinity FMS Pak
| Company | Alcon Research, LTD. |
|---|---|
| Recall number | Z-2408-2023 |
| Classification | Class II |
| Status | Ongoing |
| Category | Devices |
| Initiated | 2023-06-28 |
| Product | Infinity FMS Pak |
| Reason | Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench. |
FAQ
What did Alcon Research, LTD. recall?
Infinity FMS Pak
Why was Alcon Research, LTD.'s product recalled?
Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.