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Class 2 Device Recall BioFlo and Xcela

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Class 2 Device Recall BioFlo and Xcela

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Date Initiated by Firm	May 04, 2020
Create Date	June 17, 2020
Recall Status¹	Terminated ³ on August 23, 2023
Recall Number	Z-2397-2020
Recall Event ID	85631
Product Classification	Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
Product	BioFlo PICC and Xcela PICC Convenience 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 H96560M01162101 H96560M0116291 H96560M0133531 H96560M0134211 H96560M0198811 H96560M0224741 H96560M0224751 H96560M0335621 H96560M0367041 H96560M0367051 H96560M0367061 H96560M05019111 H96560M0501981 H96560M1201961 H96560M1201971 H96560M12202101 H96560M12202111 H96560M12202121 H96560M1303151 H96560M1303171 H96560M1303191 H96560M13184101 H96560M13184111 H96560M1318491 H96560M1401411 H96560M1401421 H96560M1401431 H96560M1401441 H96560M1406061 H96560M1406071 H96560M1633931 H96560M1803441 H96560M1803451 H96560M18157111 H96560M18157121 H96560M1841151 H96560M1841161 H96560M1841171 H96560M1907131 H96560M1907141 H96560M2204441 H96560M2208511 H96560M2208521 H96560M2322421 H96560M2500961 H96560M2500971 H96560M610115911 H96560M610901011 H96560M611025121 H96560M611025131 H96560M611052821 H96560M611056021 H96560M611056031 H96560M611095821 H96560M611095831 H965PKM030667S1 H965PKM120451S1 H965PKM1220226S1 H965PKM1300011S1 H965PKM1303119S1 H965PKM131935S1 H965PKM150124S1 H965PKM150125S1 H965PKM150127S1 H965PKM220851S1 H965PKM220854S1 H965PKM3092662S1 H965PKM61040701S1 H965PKM61066141S1 H965PKM61095321S1 H965PKM61095324S1 Cat. No. 60M0116210 60M011629 60M013353 60M013421 60M019881 60M022474 60M022475 60M033562 60M036704 60M036705 60M036706 60M0501911 60M050198 60M120196 60M120197 60M1220210 60M1220211 60M1220212 60M130315 60M130317 60M130319 60M1318410 60M1318411 60M131849 60M140141 60M140142 60M140143 60M140144 60M140606 60M140607 60M163393 60M180344 60M180345 60M1815711 60M1815712 60M184115 60M184116 60M184117 60M190713 60M190714 60M220444 60M220851 60M220852 60M232242 60M250096 60M250097 60M61011591 60M61090101 60M61102512 60M61102513 60M61105282 60M61105602 60M61105603 60M61109582 60M61109583 PKM030667S PKM120451S PKM1220226S PKM1300011S PKM1303119S PKM131935S PKM150124S PKM150125S PKM150127S PKM220851S PKM220854S PKM3092662S PKM61040701S PKM61066141S PKM61095321S PKM61095324S
Code Information	Lots 5502064 5499646 5537999* 5470193 5482411 5491837 5498227 5519222 5523176 5534734 5544000 5574435 5583228 5468490 5485176 5525973 5552143 5569544 5476092 5482007 5474457 5498239 5513077 5532408 5555127 5574431* 5465977 5474459 5491848 5513071 5534738 5559194 5576291* 5470199 5480504 5491841 5513063 5528679 5566358 5576283 5498237 5546409 5468510 5487221 5528681 5537991 5566360 5574447 5586266 5587813 5465983 5474461 5487219 5491856 5502075 5519230 5546399 5555117 5574427 5587267 5530190 5460247 5468506 5478056 5498235 5519224 5530200 5546405 5557541 5569536 5574437 5578568 5488823 5502081 5465979 5468518 5485174 5488829 5502073 5519228 5530187 5548446 5559211 5566366 5574429 5578562 5583236 5474465 5546403 5468494 5474455 5485180 5502067 5525966 5537993 5555121 5559200 5566368 5578551 5488821 5496910 5569546 5585539* 5472110 5480506 5487225 5498231 5505007 5523171 5532396 5555131 5559204 5567557 5576293 5583232 5588904 5491844 5548431 5465975 5478054 5502060* 5530198* 5463223 5468502 5502058* 5471177 5484653 5490779 5499462 5497832 5496904 5502069 5532406 5559198 5588906* 5468498 5491846 5513056 5525993 5530194 5538001 5543992 5548448 5555133 5564678 5567555* 5580574* 5477981 5482407 5530196 5536952 5548440 5557551 5571892 5574441 5564684 5589187* 5541640 5574117 5477985 5482409 5492430 5530268 5536954 5574443 5557547 5569538 5583230* 5585537* 5460261 5468500 5478052 5482403 5488817 5498223 5502071 5525986 5532400 5566362 5571890 5576273 5552141 5548438 5569540 5583214 5496380 5500241 5564686 5465971 5478048 5485170 5488813 5502079 5576281 5583226 5496902 5465981 5472108 5496914 5500251 5502083 5534736 5544004 5576289 5552135 5566347 5583234* 5491406 5494896 5497840 5500245 5481600 5487425 5491408 5496883 5498249 5500239 5497842 5488166 5491404 5497843 5552091 5494898 5500247 5463219 5480498 5487217 5513054 5525971 5528674 5557549 5576285 5580568 5546407 5564680 5583217* 5480497 5487211 5513061 5528672 5559202 5566341 5576295 5504997 5546413 5585293 5538003 5567544 5569529 5571894 5500912 5566335 5583240* 5585533* 5528685 5537995 5500914 5580580* 5472112 5487215 5498243 5523167 5544002 5559192 5564676 5567563 5580572 5583238* 5472100 5487213 5496916 5523159 5532404 5536960 5552139 5567565 5580578 5566354 5502085 5583224* 5585531* 5463229 5474453 5482413 5498241 5523165 5534782 5548442 5555129 5488827 5569534 5574445* 5588910* 5512991 5472114* 5462693 5488831 5500253 5528687 5537989 5574433 5525953 5573696 5563194 5468516 5472116 5482405 5491854 5505001 5525996 5537987 5557557 5567553 5576287 5546419 5585541* 5501847 5501849 5482397 5491850 5530183 5543998 5555119 5569527 5576279 5590986 5468508 5472102 5491852 5496918 5505009 5526008 5546411 5559209 5567548 5574439 5578555 5468504 5474451 5496912 5523161 5532398 5548444 5578558 5580570 5561831 5469652 5509008 5545799 5571567 5586750 5566047 5548436 5468496 5487223 5523163 5578560* 5519218 5523157 5552145 5571898 5519220 5560888 5513083 5589182* 5513085 5589184* 5566343 5548429 5548427 5566364* 5554712 5481669 5496098 5529915 5543929 5533714 5504525 5504776 5584036 5497505 5531858 5569315* 5560822 5480044 5527933 5568794 5536934 5559150 5592033 5470095* *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 ²	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.

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