Recall Z-0501-2020 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Angiodynamics Inc. (Navilyst Medical Inc.)
BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.
| Date | Sep 18, 2019 |
| Status | Terminated |
| Reason | Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure. |
| Root cause | Under Investigation by firm |
| Action | On September 18, 2019, AngioDynamics sent Urgent Voluntary Medical Device Letters to impacted consignees. Customers were asked to do the following: 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 AngioDynamics, Inc. o Forward a copy of this recall notification to all sites to which you have distributed affected product. IN THE EVENT THAT THE PORT PRODUCT UNDER RECALL HAS BEEN UTILIZED |
| Quantity | 582 |
| Distribution | Worldwide distribution - US Nationwide in the state of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI and country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122767 | NMI PORT Navilyst Medical, Inc., Apr 30, 2013 |