FDA Device recall Z-0585-2020
4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
- FDA Device
- Class II
- terminated
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class II recall of 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001 by Vygon Mfg Dba Churchill Medical Systems, citing potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0585-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-24 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Vygon Mfg Dba Churchill Medical Systems |
| Distribution | TN |
Product
4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
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.
Identifiers
| code_info | Product Code: VYML4S1001 Lot Number: 17B012D Exp. Date: 2021-10-31 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0585-2020%22
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