Recall Z-0596-2019 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Angiodynamics Inc. (Navilyst Medical Inc.)
BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481
| Date | Oct 16, 2018 |
| Status | Terminated |
| Reason | specific lots of Xcela Power Injectable and BioFlo PICCs are labelled with incorrect expiration dates. The labelled expiration date extends the shelf life of the product beyond the date supported by validation testing. Although the product under recall has not yet reached its validated expiry date, removal of the affected product is warranted to prevent use beyond the validated expiry date. |
| Root cause | Under Investigation by firm |
| Action | On October 16, 2018, the firm issued Urgent Voluntary Medical Device Recall letters to affected customers. The letter identified the product issue. Customers were asked to do take the following immediate actions: 1. Actions to be taken IMMEDIATELY: - Stop using the product subject to recall. - Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). - Segregate this product in a secure location for return to AngioDynamics, Inc. - Forward a copy of this recall notification to all sites to which you have dist |
| Quantity | Box of 4 units |
| Distribution | Distributed to accounts in Florida. Foreign distribution to Great Britain. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121990 | PICC CONVENIENCE KIT Navilyst Medical, Inc., Aug 3, 2012 |