CLASS II Device recall · Reported 4 Dec 2019 · FDA Enforcement Report
Single Lumen CT Midline Basic Tray, Product recalled by Vygon MFG, Inc
Vygon MFG Inc is recalling Single Lumen CT Midline Basic Tray, distributed in Tennessee. The recall was initiated on 24 Sep 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0585-2020
- FDA event ID
- 84010
- Recalling firm
- Vygon MFG Inc, Dover, NH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Sep 2019
- FDA classified
- 27 Nov 2019
- Reported
- 4 Dec 2019
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Sep 2019 | Recall initiated by company | |
| 27 Nov 2019 | Classified by FDA | +64 days |
| 4 Dec 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
Where it was distributed
One Customer Located in TN
Questions about this recall
Why was it recalled?
Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.
Which lots are affected?
Product Code: VYML4S1001 Lot Number: 17B012D Exp. Date: 2021-10-31
Where was it sold?
One Customer Located in TN
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Vygon MFG Inc
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|---|---|---|---|---|---|
| Device | CLASS II | Vygon IV Start Convenience Kits recalled by Vygon MFG, Inc | Vygon MFG Inc | Potency & Assay | NH |
| Device | CLASS II | x .75 LifeGuard Huber Needle with Y-site recalled by Vygon MFG, Inc | Vygon MFG Inc | Sterility | NH |
| Device | CLASS II | Nutrisafe 2 Syringe for Safety Connection recalled by Vygon MFG, Inc | Vygon MFG Inc | Sterility | NH |
| Device | CLASS II | CVC Tray Pediatrics recalled by Vygon MFG, Inc | Vygon MFG Inc | Sterility | NH |
| Device | CLASS II | Huber Needle Set recalled by Vygon MFG, Inc | Vygon MFG Inc | Sterility | NH |
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