Recall Z-0467-2012 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Angiodynamics Worldwide Headquarters
MORPHEUS CT PICC with STYLET, 5F Dual Lumen 65 cm Insertion Kit, Catalog No./REF 1200923, STERILE, AngioDynamics Queensbury, NY 12804 USA --- COMMON/USUAL NAME: Percutaneous, implanted, long-term intravascular catheter; CLASSIFICATION NAME: Percutaneous, implanted, long-term intravascular catheter; Device Listing # D095274. PICC Catheters are utilized for Short or Long Term peripheral access to
| Date | Jan 11, 2012 (initiated Dec 5, 2011) |
| Status | Terminated |
| Reason | AngioDynamics distributed the affected PICC catheters that were beyond their expiration date. |
| Root cause | Incorrect or no expiration date |
| Action | AngioDynamics sent an "URGENT-MEDICAL DEVICE RECALL" letter dated December 2, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. A Recall Reply Form was attached to the letter for customers to complete and return to the firm via fax at 518-798-1360. Contact your local sales representative or AngioDynamics Customer Service at 800-772-6446 for questions regarding this notice. |
| Quantity | 16 units domestically |
| Distribution | Nationwide Distribution-including the states of Florida, Georgia, Montana, and Tennessee. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030415 | ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT AngioDynamics, Inc., Apr 30, 2003 |