Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
Brand
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Lot Codes / Batch Numbers
Product Code: VYML4S1001 Lot Number: 17B012D Exp. Date: 2021-10-31
Products Sold
Product Code: VYML4S1001 Lot Number: 17B012D Exp. Date: 2021-10-31
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. is recalling 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001 due to Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential that 3Fr size catheter placed in the catheter tray instead of 4Fr for the 4Fr x 20cm Single Lumen CT Midline Basic Tray.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IN, TN
Page updated: Jan 10, 2026