FDAClass IIDecember 4, 2019

4Fr x 20cm Single Lumen CT Midline Basic Tray recall

4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001

Why was 4Fr x 20cm Single Lumen CT Midline Basic Tray 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Product Code: VYML4S1001 Lot Number: 17B012D Exp. Date: 2021-10-31

Product
4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
Recalling firm
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Quantity
75
Distribution
One Customer Located in TN
Recall date
December 4, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls