Class 2 Device Recall BioFlo Midline 5F DL20cm Max Sterile Barrier Drape Kit

• Date Initiated by Firm: May 10, 2018
• Create Date: June 14, 2018
• Recall Status: Terminated on May 13, 2020
• Recall Number: Z-2198-2018
• Recall Event ID: 80169
• 510(K)Number: K161866
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490
• Code Information: UPN: H965464901; Lot: 5302405, 5312036, 5314940
• Recalling Firm/ Manufacturer: Angiodynamics Inc. (Navilyst Medical Inc.); 10 Glens Falls Tech Park; Glens Falls NY 12801-3864
• For Additional Information Contact: David Greer; 518-795-1676
• Manufacturer Reason for Recall: A component of the kits might contain unsafe levels of bacterial endotoxins (pyrogens).
• FDA Determined Cause: Material/Component Contamination
• Action: Urgent Medical Device Recall letters were sent to customers on 5/10/18. The letters instructed customers to do the following: 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. Complete and return the Reply Verification Tracking Form. 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.
• Quantity in Commerce: 190 boxes
• Distribution: The products were distributed to the following US states: AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, WA, WI, and WV. The products were distributed to the following foreign countries: Canada, China, Ireland, Spain.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FOZ