Recall Z-1985-2016 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Navilyst Medical, Inc., an AngioDyamics Company
BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211 The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients;
| Date | Mar 14, 2016 |
| Status | Terminated |
| Reason | PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter. |
| Root cause | Device Design |
| Action | Navilyst Medical distributed Urgent Voluntary Medical Device Recall notification letters on March 14, 2016, and Reply Tracking forms to their customers via courier service. Customers were asked to immediately remove any affected (recalled) product from their inventory (whether in labs, central supply, shipping and receiving or any other location). Segregate this product in a secure location for return to Navilyst Medical. Immediately forward a copy of the recall notice to all sites to which you have distributed affected product. If affected product is located in your institution, please c |
| Quantity | 445 units |
| Distribution | Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021704 | VAXCEL PICC WITH PASV VALVE TECHNOLOGY Catheter Innovations, Inc., Jun 6, 2002 |