Recall Z-0585-2020 ยท PND Midline Catheter
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001
| Date | Sep 24, 2019 |
| Status | Terminated |
| 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 wi |
| Quantity | 75 |
| Distribution | One Customer Located in TN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181208 | Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter Vygon USA, Nov 2, 2018 |