Device product
4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
Z-0585-2020
Product summary
- Event
- Event 84010
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75
- Official record key
device-enforcement:Z-0585-2020
Official wording
Reason: Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.
Code information: Product Code: VYML4S1001 Lot Number: 17B012D Exp. Date: 2021-10-31
Distribution pattern: One Customer Located in TN
Derived failure modes
-
Unknown
Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.