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-2395-2020
• Recall Event ID: 85631
• Product Classification: Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
• Product: BioFlo Midline Catheter and BioFlo Maximal Barrier 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 H965460151 H965460161 H965460161-NP H965460171 H965460181 H965460221 H965460231 H965460241 H965460251 H965460261 H965460271 H965460281 H965460291 H965464601 H965464701 H965464701-NP H965464801 H965464901 Cat. No. 46-015 46-016 46-016-NP 46-017 46-018 46-022 46-023 46-024 46-025 46-026 46-027 46-028 46-029 46-460 46-470 46-480 46-490
• Code Information: Lots 5478035 5530253 5583183* 5462686 5468487 5487198 5505544 5519248 5526065 5530262 5534809 5536989 5546450 5567428 5569508 5571868 5576312 5583181 5501024 5501025 5564647 5488838 5478041 5585510* 5585511* 5587219* 5552115* 5478044 5530251 5559242 5585515* 5465969 5474443 5482393 5504961 5513039 5526056 5530254 5534816 5544027 5555083 5574390 5580534 5583184 5462685 5561894 5498181 5566253 5587224* 5519243 5583179* 5585513* 5587221* 5496953 5498175* 5534818* 5589118* 5513035* 5498169 5536984* 5585512* 5589119* 5513036 5474195 5474196 5528626 5496961 5494432 5505549 5546447* 5498170* 5538017* 5474199 5494439 5500300* 5532465* 5460241 5480530 5491810 5513040 5528628 5538007 5548525 5567430 5460240 5465961 5465962 5468486 5470188 5470190 5474448 5478037 5478038 5482386 5482387 5482388 5485167 5485168 5487202 5487203 5488833 5502090 5502091 5504971 5505552 5513042 5513043 5513044 5519251 5519252 5523194 5523195 5526057 5526058 5526059 5528615 5528616 5530256 5530257 5530258 5532494 5538011 5538012 5544036 5546443 5546444 5557516 5561886 5564646 5567429 5576317 5580530 5580531 5561887 5574387 5559241 5569507 5574388 5491814 5491815 5504972 5502089 5502092 5488834 5502093 5470189 5502095 5566258 5502094 5564645 5465963 5468485 5585522* 5585523* 5587229* 5589125* 5555082 5559236 5564648 5578571* 5548521 5552120 5567427 5574385 5574386 5548520 5571866 5548522 5580529* 5583188* 5587222* 5589120* 5465964 5482390 5523190 5534811 5546448 5564642 5566261 5576311 5500294 5587218* 5459121 5462681 5468482 5468483 5472092 5472093 5480535 5487199 5501018 5505554 5526060 5528619 5532459 5532460 5534817 5538013 5538014 5544035 5546449 5557515 5559238 5567433 5571865 5576316 5580535 5523191 5585518 5488835 5504967 5548527 5501016 5504966 5501020 5566260 5561891 5561892 5462682 5480534 5589127* 5585519* *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.