Dual Lumen Graft Cleaning Catheter (Applied Medical) – Tip Separation Risk (2019)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.

Recommended Action

Per FDA guidance

On November 08, 2019, a "Urgent: Medical Device Recall" letter was sent via UPS to all affected customers. In addition to providing information on the recalled products, the letter asked customers to do the following: 1. Check your inventory for the recalled product. 2. Complete the Recall Notification Confirmation Form to acknowledge the recall and indicate if your facility is returning or has already used product from the lot listed above. 3. If no product is being returned, please indicate on the Recall Notification Confirmation Form. 4. If you are a distributor, please notify any facilities to which you distributed the affected product. Please also complete Page 4 of the Recall Notification Confirmation Form. 5. Return the Recall Notification Confirmation Form to Applied Medical by email to recall60810330@appliedmedical.com or faxing it to (949) 713-8908. 6. Return affected product and a copy of the Recall Notification Confirmation Form to Applied Medical (Product Return Instructions are on Page 5). 7. For product return questions, please contact Jaclene Rios-Simpson, Senior Manager, Customer Relations at (949) 713-8688 or jrios@appliedmedical.com. 8. For regulatory questions, please contact me, Lauren Contursi, at (949) 713-8767 or lcontursi@appliedmedical.com.