FDA recall Z-0585-2020
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. · Class II · device
Product
4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
Reason for recall
Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.
Distribution
One Customer Located in TN
Key facts
- Status
- Terminated
- Initiation date
- 2019-09-24
- Report date
- 2019-12-04
- Termination date
- 2020-10-21
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Dover, NH, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0585-2020