Class 2 Device Recall BioFlo and Xcela

• Date Initiated by Firm: May 04, 2020
• Create Date: June 17, 2020
• Recall Status: Terminated on August 23, 2023
• Recall Number: Z-2398-2020
• Recall Event ID: 85631
• Product Classification: Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
• Product: BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits - Product Usage: are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Item Numbers H965750011 H965750031 H965750121 H965750131 H965750141 H965750151 H965750161 H965750171 H965750181 H965750191 H965750211 H965750221 H965750231 H965750241 H965750315 H965750315-NP H965750325 H965750335 H965750335-NP H965750345 H965750355 H965750355-NP H965750365 H965750375 H965750385 H965750415 H965750425 H965750441 H965750451 H965750471 H965750481 H965750491 H965750501 H965750521 H965750531 H965750541 H965750551 H965750561 H965750571 H965750581 H965750591 H965750601 H965750611 H965750621 H965750631 H965750651 H965750661 H965750671 H965750681 H965750691 H965750701 Cat. No. 75-001 75-003 75-012 75-013 75-014 75-015 75-016 75-017 75-018 75-019 75-021 75-022 75-023 75-024 75-031 75-032 75-033 75-034 75-035 75-036 75-037 75-038 75-041 75-042 75-044 75-045 75-047 75-048 75-049 75-050 75-052 75-053 75-054 75-055 75-056 75-057 75-058 75-059 75-060 75-061 75-062 75-063 75-065 75-066 75-067 75-068 75-069 75-070
• Code Information: Lots 5532456 5546446 5468484 5574393* 5578573* 5468479 5480529 5488836 5491816 5505550 5523189 5528614 5534810 5555087 5465967 5505541 5526062 5532463 5538009 5544033 5557511 5566262 5576313 5585520 5478042 5498174 5589122* 5491811 5571860* 5465968 5485166 5513045 5530259 5534812 5538008 5557514 5567431 5504965 5580537 5472096 5587227* 5522942 5462677 5478036 5487208 5498183 5519246 5528617 5530255 5536985 5544026 5567424 5578574 5585516 5557513 5564638 5459118 5460231 5468489 5474445 5482389 5487204 5513038 5523192 5528625 5532462 5534813 5536986 5544034 5552122 5559237 5567425 5569506 5580533 5498179 5574395 5491813 5465970 5561893 5504968 5589123* 5462684 5482396 5491812 5498177 5513041 5526061 5534814 5544028 5552119 5559239 5574394 5587217 5462678 5462679 5474447 5480531 5480532 5487206 5505542 5513049 5523196 5532461 5534815 5544030 5546451 5574392 5555084 5569505 5585517 5574391 5561889 5528618 5504959 5504960 5564649 5589121* 5460232 5472094 5488837 5513047 5532458 5544031 5559234 5583186 5566254 5480528 5519250 5552116 5487205 5504970 5528620 5544029 5555086 5557510 5567432 5571867 5576314 5580528 5478039 5564644 5566256 5585521* 5462683 5468488 5472095 5482395 5505551 5519247 5528624 5538010 5557512 5569504 5576315 5544037 5498180 5564640 5587228* 5468480 5478043 5488839 5498178 5513046 5528623 5536988 5569500 5548526 5561890 5566252 5589126* 5580536* 5552117 5460230 5474444 5482392 5505543 5530252 5536987 5555081 5569501 5564641 5587216* 5460236 5460237 5465965 5465966 5470187 5480536 5482394 5487200 5504962 5504964 5505547 5513050 5513051 5526063 5526064 5528621 5530261 5538015 5546445 5578572 5470186 5530260 5569503 5487201 5504963 5538016 5474446 5566255 5583189* 5589124* 5552121 5548524 5555085 5559235 5548523 5561888* 5566259 5571864* 5578570* 5583187* 5587225* 5563207 5468478 5480533 5487207 5504969 5519249 5528622 5564643 5574389 5587223* 5552118 5571861 5587220* 5482391 5505553 5528627 5538019 5571862 5576310 5580532 5587215 5470185 5500298 5478040 5500299 5528613 5536990 5583242 5569499 5460234 5468481 5480527 5485169 5498185 5513048 5523193 5532457 5544032 5548528 5569502 5559240 5585514 5472097 5566257 5505546 5564639 5472091 5532493 5567426 5498176 5559233 5571863* 5474201* 5474202* 5498172* 5534819* 5583180* 5587226* 5498171 5528629* 5494440 5474203 5498182* 5513037* 5474204 5494441* 5505548* 5538018* 5474205* 5583185* 5474206 5505537* 5474207* 5502096* 5583182* 5474190 5505538* 5474188 5474189* 5536983* 5519244* 5505539* 5474191 5474200* 5474197 5474192* 5519245 5544025* 5474198* 5505545* 5474193* 5498173* 5532464* 5474194* 5496954* 5498184* 5526055 *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.