FDA Medical Device Recalls (openFDA)
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.: 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
- Recall number
- Z-0585-2020
- Recalling firm
- Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
- Product
- 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
- Status
- Terminated
- Initiated
- 2019-09-24
- Posted
- not on file
- Terminated
- 2020-10-21
- 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.
- 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 customerservice@vygonus.com.
- Quantity
- 75
- Distribution
- One Customer Located in TN
- Lot, serial or model codes
- Product Code: VYML4S1001 Lot Number: 17B012D Exp. Date: 2021-10-31
- 510(k) numbers
- ["K181208"]
- PMA numbers
- not on file
- Product code
- PND
- Firm FEI
- 1000120555
- Firm city
- Dover
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28