Recall Z-0240-2018 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Angiodynamics Inc. (Navilyst Medical Inc.)
Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administrat
| Date | Nov 28, 2016 |
| Status | Terminated |
| Reason | Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer. Greatbatch Medical determined that the products listed in their 11/11/2016 Recall Notification have the potential for the handles to detach from the sheath during use. NMI has confirmed that the affected sheaths, Greatbatch Model Number 10890-006, had been included in packaged Xcela and BioFlo PICC Kits. |
| Root cause | Component design/selection |
| Action | The firm, Navilyst Medical, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL IMMEDIATE ACTION REQUIRED" letter dated 11/28/2016 by issuing recall notifications to consignees via Federal Express. The letter described the product, problems and actions to be taken. The Consignees were instructed to 1. IMMEDIATELY o Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). o Segregate this product in a secure location for return to Navilyst Medical, Inc. (an AngioDynamics C |
| Quantity | 4591 units in total |
| Distribution | Worldwide Distribution: US (Nationwide) and countries of:; Canada, Great Britain, Netherlands, South Australia and Spain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091261 | NMI PICC Navilyst Medical, Inc., May 12, 2009 |