4Fr x 20cm Single Lumen CT Midline Basic Tray — Class II medical device recall Z-0585-2020
Terminated recall by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., reported 2019-12-04, distributed in TN. Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT
| Recall number | Z-0585-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc., Dover, NH, United States |
| Recall initiated | 2019-09-24 |
| Classified | 2019-11-27 |
| Reported by FDA | 2019-12-04 |
| Terminated | 2020-10-21 |
| Distributed | TN |
| Quantity | 75 |
| Lot numbers | 17B012D |
| Expiration dates | 2021-10-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0585-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.