| | Class 2 Device Recall Presource Convenience Kit |  |
| Date Initiated by Firm | October 01, 2026 |
| Date Posted | November 13, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0461-2027 |
| Recall Event ID |
100062 |
| Product Classification |
Neurological tray - Product Code OJG
|
| Product | Presource Convenience kits containing recalled WelMed Extension Tubing Sets
ALLIANCE LUMBAR PUNCTURE TRAY
26-0286B
26-0286C
26-0286D
CUSTOM LUMBAR PUNCTURE PACK B
SAN12LPYHD
ENS PONCTION LOMBAIRE CH GRANB
SAN30LPGBD
FORAMINOTOMY PACK
SNE54CNFPA
LUMBAR PUNCTURE
SBA30LBNHE
LUMBAR PUNCTURE 20GX3 5 TRAY
26A8060E
26A8060F
26A8060G
LUMBAR PUNCTURE 22GX3 5
26-LP3COA
LUMBAR PUNCTURE KIT
26-8061L
26-8061M
26-8061N
LUMBAR PUNCTURE PACK
SBA30LBNHF
LUMBAR PUNCTURE PACK B
SAN12LPYHE
LUMBAR PUNCTURE TRAY
26-0413F
26-0575F
26A6667H
26A6667I
26A6667J
26B4610H
26B4610I
SBA30LBYCC
MYELOGRAM LUMBAR TRAY
27-2907H
27-2907J
MYELOGRAM PACK
SAN5CMPGSG
MYELOGRAM TRAY
27-2755A
27-6335A
27-6335B
27-6335C
27-9818A
27-9836A
27-9836B
SAFETY LMBR PNCTR 20GX3 5 TRAY
26-9456E
26-9456F
26-9456G
26-9456H
SAFETY LP 22GX3 5 ATRAUMATIC
26-LP4SFA
SAFETY LP TRAY
26-9079E
26-9079F
SAFETY LUMBAR PUNCT:ADULT/PEDS
SOP30LP11C
SAFETY LUMBAR PUNCTURE 20GX3 5
26-LP1SFA
SAFETY LUMBAR PUNCTURE TRAY
SOP30LP01C
SOP30LP06C
SOP30LP11C
SOP30LPHRC
SAFETY LUMBAR PUNCTURE: ADULT
SOP30LP01C
SAFETY LUMBAR PUNCTURE:ADULT
SOP30LP06C
STND CAN LUMBAR PUNCT AD PED
SOP30LP11C
STND CAN LUMBAR PUNCT ADULT
SOP30LP01C
STND CAN LUMBAR PUNCTURE
SOP30LP06C
STND CAN MYELOGRAM TRAY
27-5687A |
| Code Information |
26-0286B
UDI-DI 10888439530902
Kit lot 368976
26-0286C
UDI-DI 10197106919804
Kit lot 446910
453697
26-0286D
UDI-DI 10197106978252
Kit lot 473616
SAN12LPYHD
UDI-DI 10197106466032
Kit lots 248082
255134
256005
484940
515017
SAN30LPGBD
UDI-DI 10197106663554
Kit lots 292409
326997
351716
380956
483328
658976
701476
770031
SNE54CNFPA
UDI-DI 10197106712610
Kit lot 323473
SBA30LBNHE
UDI-DI 10197106084304
Kit lot 237175
295385
26A8060E
UDI-DI 10888439747966
Kit lot 509302
26A8060F
UDI-DI 10197106577073
Kit lots 510205
510253
510873
510963
26A8060G
UDI-DI 10197106642894
Kit lots 512844
514059
514060
514061
514062
515637
515969
516353
517030
517205
517293
518538
518539
519395
519858
520050
520929
521111
26-LP3COA
UDI-DI 10197106061732
Kit lots 509965
511338
511784
512451
512633
512687
512994
513774
514113
514116
514426
514598
514992
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515626
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517104
517171
517666
517986
518115
518548
518549
519046
519047
519094
519098
519102
519105
519230
519383
519698
519731
520087
520371
520389
520601
520632
520633
520671
521226
521322
521324
521990
521991
522130
26-8061L
UDI-DI 10195594717001
Kit lots 212324
228588
26-8061M
UDI-DI 10197106632628
Kit lot 260396
26-8061N
UDI-DI 10197106678930
Kit lots 308280
361900
494359
516049
532252
568922
593429
604987
609506
614483
799425
SBA30LBNHF
UDI-DI 10197106694954
Kit lots 311717
326546
347597
374619
SAN12LPYHE
UDI-DI 10198956087811
Kit lots 562034
579101
599459
679395
707843
721389
753844
26-0413F
UDI-DI 10197106401323
Kit lots 509571
510427
510502
511123
512649
512804
513416
514072
515918
516214
516951
517774
518529
518941
520031
520862
521383
26-0575F
UDI-DI 10195594867164
Kit lots 188859
258937
264103
267850
271323
278748
543119
576841
614482
650937
720545
799424
26A6667H
UDI-DI 10197106496527
Kit lot 235552
26A6667I
UDI-DI 10197106600511
Kit lots 248248
271314
275900
26A6667J
UDI-DI 10197106659656
Kit lots 340943
459949
26B4610H
UDI-DI 10195594767402
Kit lots 312557
349207
373310
404587
428232
434853
452602
26B4610I
UDI-DI 10197106981269
Kit lots 474621
533855
SBA30LBYCC
UDI-DI 10195594880835
Kit lots 295361
304663
362534
373691
389172
389173
391965
413241
491893
579690
652793
691348
723253
769606
27-2907H
UDI-DI 10195594890667
Kit lots 246607
257953
317550
360029
493864
27-2907J
UDI-DI 10198956079939
Kit lots 524808
665504
749638
SAN5CMPGSG
UDI-DI 10198956007437
Kit lots 517075
520002
27-2755A
UDI-DI 10198956208537
Kit lots 519439
519748
27-6335A
UDI-DI 10195594777098
Kit lots 509163
510428
510506
511125
511557
512159
512411
512822
513122
513972
514223
514394
514599
514714
514761
514990
515159
515273
515332
515996
517294
518589
519302
519859
27-6335B
UDI-DI 10198956309456
Kit lot 520336
27-6335C
UDI-DI 10198956355019
Kit lots 520930
521013
521945
27-9818A
UDI-DI 10197106985212
Kit lots 516355
517296
517561
517668
517800
518967
519219
519273
27-9836A
UDI-DI 10197106015964
Kit lots 509689
509797
510615
510825
511202
511765
512066
512293
512480
513324
516500
516868
516953
517908
520011
520674
521211
27-9836B
UDI-DI 10198956483910
Kit lot 521971
26-9456E
UDI-DI 10197106585023
Kit lots 237595
249009
26-9456F
UDI-DI 10197106647370
Kit lots 314110
360010
388284
398009
442681
455895
482954
528559
26-9456G
UDI-DI 10198956150898
Kit lot 579329
26-9456H
UDI-DI 10198956182936
Kit lots 624793
645427
720504
26-LP4SFA
UDI-DI 10197106061701
Kit lots 512534
512865
513415
514055
514056
514096
514544
514988
515899
516213
516387
516606
516895
517233
517944
517945
518292
518293
518869
519326
519626
519857
520116
521320
522148
26-9079E
UDI-DI 10195594698850
Kit lots 250908
322683
353040
381918
419293
428219
449618
462795
488769
26-9079F
UDI-DI 10198956047648
Kit lots 524785
562269
617862
631562
675570
721615
746349
766275
SOP30LP11C
UDI-DI 10887488563206
Kit lots 201529
216120
26-LP1SFA
UDI-DI 10197106061749
Kit lots 509314
509735
509971
509972
509973
510515
510674
510766
510767
511023
511070
511728
511729
511750
511777
511793
511794
512544
512587
512661
512789
513369
513792
514054
514102
514125
514148
514171
514193
514235
514239
514262
514306
514330
514353
514377
514400
514424
514447
514490
515113
515154
515597
515621
515694
515727
515817
515854
516093
516119
516120
516202
516234
516235
516520
516649
516655
516656
516657
516937
516938
517563
517592
517625
517897
517919
517959
518148
518168
518228
518325
518326
518327
518329
518507
518560
518580
518605
518606
518925
518949
518950
518990
519264
519277
519295
519308
519322
519323
519388
519423
519453
519603
519685
519708
519766
519767
519804
519902
519916
519917
520041
520042
520060
520698
520714
520730
520748
520827
520906
520955
521273
521349
521363
521378
521407
521423
521438
521528
521709
521759
521776
SOP30LP01C
UDI-DI 10887488563169
Kit lots 558945
564522
581666
SOP30LP06C
UDI-DI 10887488563213
Kit lots 558946
786279
786280
SOP30LP11C
UDI-DI 10887488563206
Kit lots 608197
776906
SOP30LPHRC
UDI-DI 10888439818260
Kit lots 283070
300471
323375
368014
389267
605513
649446
658998
666324
749434
791413
795979
SOP30LP01C
UDI-DI 10887488563169
Kit lots 200399
217135
227424
230671
SOP30LP06C
UDI-DI 10887488563213
Kit lots 200400
216119
SOP30LP11C
UDI-DI 10887488563206
Kit lots 271633
296400
300714
376711
399446
407117
488081
491743
497888
504056
552495
572502
622869
656448
667693
693090
726564
726565
751323
804513
810909
810910
SOP30LP01C
UDI-DI 10887488563169
Kit lots 250866
276773
283928
295650
307635
362615
368015
376715
389170
389171
396005
404722
429410
498042
552493
578785
607152
608194
612013
629884
643537
644638
687623
688936
724005
732390
734347
737628
739092
785698
798273
SOP30LP06C
UDI-DI 10887488563213
Kit lots 250146
268029
276078
295377
295668
343354
382164
384254
394095
432800
504064
518965
531461
542072
572501
581667
607166
617433
622868
643539
644631
672215
679743
711342
732392
736438
750011
750012
767729
27-5687A
UDI-DI 10197106708309
Kit lots 326116
|
| FEI Number |
3001236905
|
Recalling Firm/ Manufacturer |
Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan
IL
60085-8337
|
| For Additional Information Contact | Janna Parks 847-887-1114 |
Manufacturer Reason for Recall | Kits include Extension Tubing Sets recalled by supplier WelMed. Affected tubing sets may leak. |
FDA Determined Cause 2 | Component design/selection |
| Action | Firm began notifying customers on October 1, 2026.
Prior to use, users should visually inspect the tubing connection area, including bonded junctions and connection points, for any visible irregularities, gaps, deformation, incomplete bonding, leakage, or other abnormalities consistent with the examples shown above.
If a defect is observed, or if leakage or connection difficulties are encountered during setup or priming, the product should not be used for patient care and discarded. Customers should report affected product through their normal complaint reporting process and retain the product for evaluation if requested.
Direct consignees were instructed to notify retail customers of the market action. |
| Quantity in Commerce | 1,155,430 |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| 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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