FDA recall Z-1653-2022
Baxter Healthcare Corporation · Class I · device
Product
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. An in-line injection site.
Reason for recall
Firm noted an increase in customer reports of leaks.
Distribution
US Nationwide Distribution
Key facts
- Status
- Terminated
- Initiation date
- 2022-08-09
- Report date
- 2022-09-21
- Termination date
- 2024-08-09
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Deerfield, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1653-2022