Z-0585-2020 Class II Terminated
FDA device recall Z-0585-2020 was initiated by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. on September 24, 2019 and is designated Class II. 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. The recall status is terminated (terminated October 21, 2020). Affected quantity: 75.
Recall Details
- Product Type
- Devices
- Report Date
- December 4, 2019
- Initiation Date
- September 24, 2019
- Termination Date
- October 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75
Product Description
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 Pattern
One Customer Located in TN
Code Information
Product Code: VYML4S1001 Lot Number: 17B012D Exp. Date: 2021-10-31