Recall Z-0714-2017 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Angiodynamics Inc. (Navilyst Medical Inc.)
Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The 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
| Date | Jun 8, 2016 |
| Status | Terminated |
| Reason | There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016. |
| Root cause | Mixed-up of materials/components |
| Action | Angiodynamics, Inc. (Navilyst Medical, Inc.) sent an Urgent Voluntary Medical Device Recall letter dated June 8, 2016, with reply forms to all affected customers. Customers were advised to immediately remove any affected product from inventory, segregate and secure in a location for return. Immediately forward a copy of the recall notification to all sites to which they have distributed affected product. If affected product is located in your institution, please call Navilyst Medical Customer Service at 1-800-772-6446 8am-7pm, EST Monday - Friday to obtain a replacement or credit for you |
| Quantity | 48 cartons (boxes of 5) |
| Distribution | Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142616 | PICC Maximal Barrier Nursing Kit Navilyst Medical, Inc., Oct 14, 2014 |