Recall Z-1069-2012 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Angiodynamics Worldwide Headquarters
AngioDynamics SPECIAL ORDER Morpheus Smart PICC CT --- 4F Single Lumen 65cm --- Max CT Flow Rate: 4mL/sec --- Kit Contains: --- 1 each Nitinol Guidewire, 0.46mm (0.018in.) x 130cm --- Catalog No. [REF] 52110902 --- [Mfg symbol] AngioDynamics, Inc., 603 Queensbury, NY USA 12804. Indicated for short or long term peripheral access to the central venous system for intravenous therapy and power inject
| Date | Feb 21, 2012 (initiated Feb 6, 2012) |
| Status | Terminated |
| Reason | The Morpheus Smart PICC label states the kit contains a Nitinol guidewire; however the kit contains a Platinum guidewire. |
| Root cause | Labeling mix-ups |
| Action | AngioDynamics sent an "URGENT-MEDICAL DEVICE RECALL" letter dated February 2, 2012 to the single customer. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs the customer to identify and segregate the affected product. A Morpheus Smart PICC Recall Reply Form was enclosed for the customer to complete and return via fax to 518-798-1360. Contact AngioDynamics Customer Service at 1-800-772-6446 for questions regarding this notice. |
| Quantity | 25 units |
| Distribution | Distributed to one customer in Wisconsin. |
| 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 |