Class 2 Device Recall BioFlo Midline

• Date Initiated by Firm: May 04, 2020
• Create Date: June 17, 2020
• Recall Status: Terminated on August 23, 2023
• Recall Number: Z-2396-2020
• Recall Event ID: 85631
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: BioFlo Midline Convenience Kits - Product Usage: These introducers are used for the percutaneous introduction of diagnostic or therapeutic devices, such as catheters or pacing leads in the vasculature. Item Numbers H96560M0125711 H96560M0133541 H96560M0354721 H96560M0367081 H96560M05019121 H96560M05019131 H96560M1220291 H96560M1303161 H96560M1303181 H96560M1318211 H96560M1408911 H96560M1429481 H96560M1803431 H96560M18157131 H96560M2208531 H96560M2208541 H96560M2500981 H96560M611025111 H96560M611052811 H96560M611056011 H96560M611095811 H965PKM1387818S1 H965PKM1404211S1 H965PKM1635214S1 H965PKM220533S1 H965PKM220853S1 H965PKM220855S1 H965PKM61095322S1 H965PKM61102511S1 Cat. No. 60M012571 60M013354 60M035472 60M036708 60M0501912 60M0501913 60M122029 60M130316 60M130318 60M131821 60M140891 60M142948 60M180343 60M1815713 60M220853 60M220854 60M250098 60M61102511 60M61105281 60M61105601 60M61109581 PKM1387818S PKM1404211S PKM1635214S PKM220533S PKM220853S PKM220855S PKM61095322S PKM61102511S
• Code Information: Lots 5513075 5543988 5569542 5580342* 5488819 5513069 5555125 5569548 5454444 5469653 5503014 5505722 5463227 5468512 5480502 5502087 5519226 5530266 5546401 5552137 5569550 5488815 5580584* 5474463 5513067 5571888 5462690 5472106 5502077 5513079 5528683 5546415 5557545 5566356 5488825 5530192 5576297* 5580586* 5588914* 5468514 5478046 5491839 5496906 5500243 5536950 5574449 5587258 5564674 5470097 5470834 5477983 5482399 5532402 5536956 5567559 5571900 5578553 5543994 5588900* 5574116 5477356 5479479 5492926 5497561 5542304 5550981 5504522 5542305 5584024 5584039 5470195 5472104 5477938 5505005 5523169 5528676 5534740 5539980 5498245 5564682 5571896* 5580582* 5587276* 5468492 5470191 5472098 5488811 5505003 5532394 5536962 5557555 5567546 5587263* 5501851 5501853 5470197 5480508 5500249 5504999 5523173 5546417 5566339 5530185 5519216 5523155 5526006 5536958 5559207 5585529* 5587815* 5560886 5513081 5539976 5589180* 5557537 5548425 5505070 5481670 5486489 5536936 5504526 5504527 5477373 5586746 *All units of these lots are within AngioDynamics control (US and OUS Inventory) and not distributed, therefore, removed from recall notification.
• Recalling Firm/ Manufacturer: Angiodynamics, Inc.; 603 Queensbury Ave; Queensbury NY 12804-7619
• For Additional Information Contact: David Greer; 518-795-1676
• Manufacturer Reason for Recall: Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.
• FDA Determined Cause: Process control
• Action: The firm distributed URGENT VOLUNTARY MEDICAL DEVICE RECALL letters to affected customers on May 4, 2020. Customers were instructed to segregate and return affected devices to AngioDynamics, and to complete and return the reply verification tracking form provided with the recall notification. 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. The letter included instructions on packaging and returning the recalled product.
• Quantity in Commerce: 119723 eaches total
• Distribution: US Nationwide distribution.
• 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.