| | 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-0460-2027 |
| Recall Event ID |
100062 |
| Product Classification |
Lumbar puncture tray (adult & pediatric) - Product Code PWY
|
| Product | Presource Convenience kits containing recalled WelMed Extension Tubing Sets
ADULT LUMBAR PUNCTURE TRAY
26-7824C
26-7824D
ADULT LUMBAR TRAY
26-9836A
26-9836C
LUMBAR PUNCTURE DF
26-LP3CODA
LUMBAR PUNCTURE 18GX3 5
26-LP6COA
LUMBAR PUNCTURE PACK
SAN40LPSL1
SAN40LPSL3
LUMBAR PUNCTURE PACK LG
26-1256D
LUMBAR PUNCTURE PEDIATRIC TRAY
26-1303E
26-1303G
26-1303I
26-1303K
26-1303L
LUMBAR PUNCTURE TRAY
26-2755A
26-2755B
26-6326E
26-9818A
26-9818B
PEDIATRIC INFANT LUMBAR W NDL
99-LP1COA
PEDIATRIC LUMBAR PUNCTURE TRAY
26A4610D
PEDIATRIC TRAY
26-6142A
SAFETY LP PEDIATRIC 22GX1,5 DF
26-LP2SFDA
SAFETY LP PEDIATRIC 22GX1.5 DF
26-LP2SFDA
SAFETY LP PEDS 22GX1,5 DF KIT
26-2808F
SAFETY LUMBAR PNCT 20GX3.5 ,DF
26-LP1SFDA
SAFETY LUMBAR PNCT 22GX3.5 DF
26-LP3SFDA
SAFETY LUMBAR PUNCTURE 18GX3 5
26-LP6SFA
SAFETY LUMBAR PUNCTURE 22GX3 5
26-LP3SFA
SAFETY LUMBAR PUNCTURE TRAY
26-0939A
SAFTEY LUMBAR PNCT 20GX3,5, DF
26-LP1SFDA
SAFTY LUMB PNCT 22GX3,5 KIT
26A2808G
26A2808H
26A2808I |
| Code Information |
26-7824C
UDI-DI 10195594767532
Kit lots 190330
267395
284989
320801
382636
427189
443289
446073
457454
482973
533842
562280
576842
583519
592693
609133
652067
26-7824D
UDI-DI 10198956353411
Kit lots 717918
807768
26-9836A
UDI-DI 10197106015926
Kit lots 510344
510504
512478
513322
516434
516591
516898
26-9836C
UDI-DI 10198956095670
Kit lots 518023
520062
521970
26-LP3CODA
UDI-DI 10197106326954
Kit lots 186057
387833
687821
700032
26-LP6COA
UDI-DI 10197106328972
Kit lots 514082
514083
514119
514509
514588
515125
515126
515708
515946
516013
516444
516735
517105
518680
518681
519300
519490
520184
520479
520876
521174
521294
521295
SAN40LPSL1
UDI-DI 10198956487437
Kit lot 521699
SAN40LPSL3
UDI-DI 10198956517431
Kit lot 522076
26-1256D
UDI-DI 10195594732950
Kit lots 511426
511527
511950
512145
513274
513457
517481
517667
518581
518582
518897
519056
519301
26-1303E
UDI-DI 10197106205198
Kit lots 510028
511695
512467
513350
513785
513786
515032
515612
516243
516244
516842
517648
518787
518898
26-1303G
UDI-DI 10198956197312
Kit lots 519286
519745
26-1303I
UDI-DI 10198956336674
Kit lots 520543
26-1303K
UDI-DI 10198956419179
Kit lot 521130
26-1303L
UDI-DI 10198956421646
Kit lot 521487
26-2755A
UDI-DI 10198956208520
Kit lots 519438
519677
26-2755B
UDI-DI 10198956369375
Kit lot 520741
26-6326E
UDI-DI 10198956429062
Kit lots 521217
521218
521263
26-9818A
UDI-DI 10197106892992
Kit lots 515271
516695
516696
516736
516897
516972
26-9818B
UDI-DI 10198956082106
Kit lots 517337
517394
518554
520421
520590
99-LP1COA
UDI-DI 10197106326336
Kit lots 508775
510243
510535
511662
512351
512396
520034
520502
520985
521052
521183
521452
521662
522001
522166
26A4610D
UDI-DI 10197106458075
Kit lot 511280
26-6142A
UDI-DI 10197106729212
Kit lot 512911
26-LP2SFDA
UDI-DI 10197106326961
Kit lots 387832
587920
609493
649993
26-LP2SFDA
UDI-DI 10197106326961
Kit lots 731826
771268
806419
811016
26-2808F
UDI-DI 10197106494134
Kit lots 308279
361855
441427
581444
653284
26-LP1SFDA
UDI-DI 10197106326992
Kit lots 779511
804882
26-LP3SFDA
UDI-DI 10197106326978
Kit lots 687822
693440
698625
26-LP6SFA
UDI-DI 10197106326930
Kit lots 512456
514107
514108
515611
516475
517355
519369
519883
520061
521227
521301
26-LP3SFA
UDI-DI 10197106326916
Kit lots 509148
510945
511200
511810
512326
512612
512614
512615
513741
514076
514077
514207
514543
515123
515124
515269
515513
516344
516345
516474
516894
517232
517636
517637
517991
518288
518289
518340
518896
519464
519580
519718
519874
519979
520127
520321
521240
521252
521253
521558
522101
522147
26-0939A
UDI-DI 10197106859261
Kit lots 679636
796561
26-LP1SFDA
UDI-DI 10197106326992
Kit lots 217027
225959
344643
358146
390633
395697
427188
445056
453685
460255
479323
482906
506876
533817
554293
574325
584300
589172
643199
683527
700970
737051
768685
26A2808G
UDI-DI 10197106493144
Kit lots 238823
273130
289872
308281
324935
388310
26A2808H
UDI-DI 10197106914151
Kit lots 440023
440717
26A2808I
UDI-DI 10197106993941
Kit lots 495749
527711
581446
617863
638061
697003
714273
763530
|
| 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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