Recall Z-0906-2012 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Angiodynamics Worldwide Headquarters
AngioDynamics Morpheus Smart PICC CT 5F Dual Lumen w/ Reverse Taper 55cm --- Max CT Flow Rate: 5mL/sec --- Catalog No.: 12110936 --- AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY 12804 --- Assembled and Packaged in the USA. indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media.
| Date | Jan 26, 2012 (initiated Jan 9, 2012) |
| Status | Terminated |
| Reason | The red luer on the Morpheus CT PICC (Peripherally Inserted Central Catheter) has the potential to crack during use of the product. |
| Root cause | Nonconforming Material/Component |
| Action | AngioDynamics, Inc. sent an Urgent - Medical Device Recall letter dated January 5, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify and segragate the recalled affected product. Complete the enclosed Morpheus Ct PICC Recall Reply Form and fax it to the attention of the Morpheus CT PICC Recall Coordinator at 518-798-1360. If customers do not have any affected product remaining in their possession they should fill out the attached form noting zero quantity to be returned and fax th |
| Quantity | 695 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093406 | MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 AngioDynamics, Inc., Mar 25, 2010 |