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

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Product Code: VYML4S1001 Lot Number: 17B012D Exp. Date: 2021-10-31
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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

Distribution:

Distributed in: TN

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0585-2020

Related Recalls

3-Way Standardbore Stopcock. Product Code: AMS-100.

Vygon MFG, Inc., dba/ Churchill Medical Systems

Class I - Dangerous

Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.

Jul 24, 2017 Other Medical Devices View Details →

19Ga x 1 Huber Needle Set. Product Code: MBS-1910.

Vygon MFG, Inc., dba/ Churchill Medical Systems

Class I - Dangerous

Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.

Jul 24, 2017 Surgical Instruments View Details →