BioFlo PICC with ENDEXO and PASV, ( RS 5F DL BIOFLO PASV - MEMORIAL HOSPITAL SYSTEM (LTP) PG) Cat. no. 60M183481

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.

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 distributed affected product. - No actions are required on product that has been used or is presently in-use; the affected product is within its validated expiry 2. Complete and return the Reply Verification Tracking Form. - For any affected product to be returned, please call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. - Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form. - Email Reply Verification Tracking Form (preferred): [email protected] - Fax Reply Verification Tracking Form: Attn: Xcela and BioFlo Recall Coordinator Fax number 1-800-782-1357 3. Package and Return the Recalled Product. - Package any product that is being returned in an appropriate shipping box. - Write the RMA number on the RMA/Address label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. - Please use our FedEx Account Number (284750594) to return this package via second day delivery. - Seal the box and return to: AngioDynamics, Inc. 603 Queensbury Avenue Queensbury, NY 12804 Attn: Xcela and BioFlo Re