Recall Z-1898-2009 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Angiodynamics, INC
SmartPort CT Port Access System, Catalog number CT80STPD, AngioDynamics Incorporated The SmartPort CT Port Access System is indicated for any patient requiring repeated access of the vascular system or other selected body site, for delivery of medications, nutritional supplementation, fluids, blood products, and sampling of blood.
| Date | Sep 1, 2009 (initiated Jul 16, 2009) |
| Status | Terminated |
| Reason | The product may contain an incorrect size catheter and introducer. |
| Root cause | Packaging process control |
| Action | Notification of the AngioDynamics, Inc. sales force began on July 16, 2009 and they were asked to assist in the return of all affected devices to the Manchester, GA division of AngioDynamics, Inc. Urgent Recall letters were sent to all customers on July 16, 2009, requesting the completion of a FAX BACK form. Those currently in possession of any remaining devices will be provided a Return Goods Authorization (RGA) number and pre-paid shipping boxes for return of the product to AngioDynamics, Inc. All returned devices will be physically and electronically quarantined until final disposition of |
| Quantity | 150 kits |
| Distribution | AL, CA, CO, FL, GA, ID, IL, IN, KS, LA, MI, MO, MN, MS, NC, NY, OH, OR, PA, TN and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081472 | SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS AngioDynamics, Inc., Sep 23, 2008 |