Z-0585-2020 Class II Terminated
FDA device recall Z-0585-2020 was initiated by Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. on Sep 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 Oct 21, 2020). Affected quantity: 75.
Recall details
- Product Type
- Devices
- Report Date
- Dec 4, 2019
- Initiation Date
- Sep 24, 2019
- Termination Date
- Oct 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0585-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026