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U.S. Department of Health and Human Services

Class 2 Device Recall BioFlo and Xcela

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  Class 2 Device Recall BioFlo and Xcela see related information
Date Initiated by Firm May 04, 2020
Create Date June 17, 2020
Recall Status1 Open3, Classified
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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