Device Recall Xcela PICC Kit with ENDEXO and XCELA PASV 5F DL 55CM MST70 Nitinol KIT PG 의 리콜

Recall

76570

Class 2

Z-0240-2018

2016-11-28

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153553

Navilyst medical, inc. (nmi) the manufacturer of the xcela picc with pasv, bioflo picc with pasv and the bioflo picc, conducted this recall to the end user level based on information received from greatbatch medical, the manufacturer of the viapeel ptfe peelable introducer. greatbatch medical determined that the products listed in their 11/11/2016 recall notification have the potential for the handles to detach from the sheath during use. nmi has confirmed that the affected sheaths, greatbatch model number 10890-006, had been included in packaged xcela and bioflo picc kits.

The firm, Navilyst Medical, sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL IMMEDIATE ACTION REQUIRED" letter dated 11/28/2016 by issuing recall notifications to consignees via Federal Express. The letter described the product, problems and actions to be taken. The Consignees were instructed to 1. 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 Navilyst Medical, Inc. (an AngioDynamics Company) o Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. Complete and return the Reply Verification Tracking Form. o If affected product is located in your institution, 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. o 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. o Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com o Fax Reply Verification Tracking Form: Attn: ViaPeel Recall Coordinator Fax number 1-800-782-1357 3. Package and Return the Recalled Product to: AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804, Attn: ViaPeel Recall Coordinator and complete and return the Reply Verification Tracking Form, provided in the recall notification. Attn: ViaPeel Recall Coordinator. If you have any questions, please call: 518-795-1358 or 518-795-1116.