Angiodynamics, Inc.: Certain AngioDynamics PICC Kits contain BD PosiFlush SF Saline Flush Syringes which were recalled by BD Medical on April 16, 2020.

Agency Publication Date: June 17, 2020

Affected Products

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

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.

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 H96560

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.

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

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.

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 H965

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.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85631

Status: Resolved

Manufacturer: Angiodynamics, Inc.

Manufactured In: United States

Units Affected: 4 products (119723 eaches total)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products