Z-0585-2020Class II

4Fr x 20cm Single Lumen CT Midline Basic Tray

Name: Z-0585-2020 4Fr x 20cm Single Lumen CT Midline Basic Tray
Creator: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Published: 2019-09-24
License: https://open.fda.gov/license/

Vygon Mfg / initiated 2019-09-24 / Terminated / root cause: packaging

FDA source

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. began a recall of 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001 on 2019-09-24. FDA classified it as Class II and gives the reason as "Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0585-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-24
Posted: 2019-11-27
Terminated: 2020-10-21
Recalling firm: Vygon Mfg
Product: 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
Product code: PND Midline Catheter
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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: On September 25, 2019 the firm distributed Urgent Medical Device Recall Communication letters by e-mail instructing them to: 1. Check your stock for the products included within the scope of the recall. Immediately cease use and distribution, and quarantine all affected product immediately. 2. Count and document your affected inventory on the Recall Acknowledgement and Inventory Return Form in Attachment 1. Please complete and return the document even if you currently have no product on hand. 3. Fax or email the form to Vygon including customer contact information. 4. Vygon customer service will contact the customer and issue a Return Merchandise Authorization number. 5. Return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up. 6. All inventory will be credited or replaced at no cost to you. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If you have any questions, please contact your local sales representative or Vygons Customer Service Department at 1-800-473-5414 Monday-Friday 8am 6pm, or by e-mail at [email protected].
Quantity in commerce: 75
Distribution: One Customer Located in TN
Product codes and lots: Product Code: VYML4S1001 Lot Number: 17B012D Exp. Date: 2021-10-31

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0585-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0585-2020	Class II	Terminated	Voluntary: Firm initiated	2019-12-04	2019-11-27

Product code PND

K181208Class IIVygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL CatheterVygon USA / cleared 2018-11-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)