Class 2 Device Recall Presource Convenience Kit

• Date Initiated by Firm: October 01, 2026
• Date Posted: November 13, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0457-2027
• Recall Event ID: 100062
• Product Classification: General surgery tray - Product Code LRO
• Product: Presource Convenience kits containing recalled WelMed Extension Tubing Sets AMNIOCENTESIS 20GX3,5 29-AM1COA ARTHO MYLEO COMBO KIT 28-6325A BIOPSY TRAY SBA53BSGR4 SBA53BSGRI SNU12BSSAE COMBINATION TRAY 34A7423F 34A7423G CT INTERVENTIONAL PACK SAN23LPDH4 SAN23LPDHA CT ULTRASOUND PACK W INSTMT SAN1DCUAM4 SAN1DCUAMD SAN1DCUAME DANE BIOPSY TRAY SAN52BBWH6 SAN52BBWH7 SAN52BBWHL SAN52BBWHM DRAINAGE TRAY SBA1DDRU38 SBA1DDRU39 SBA1DDRU40 SBA1DDRU41 SBA1DDRU42 SBA1DDRU43 SBA1DDRU44 SBA1DDRU45 SBA1DDRU46 SBA1DDRU47 SBA1DDRU48 SBA1DDRU49 SBA1DDRU50 SBA1DDRU51 SBA1DDRU52 SBA1DDRU53 SBA1DDRU54 SBA1DDRUNH SBA1DDRUNI EP PACK SAN1DEPUNB IR ANGIO PACK SAN23IAVA3 SAN23IAVA4 SAN23IAVA5 SAN23IAVA6 SAN23IAVA7 SAN23IAVAB IUS KIDNEY TRANSPLANT PACK SBACGKTU10 SBACGKTU11 SBACGKTU12 SBACGKTU13 SBACGKTU14 SBACGKTU15 SBACGKTU16 SBACGKTU17 SBACGKTU18 SBACGKTUH4 SBACGKTUH5 SBACGKTUH6 SBACGKTUH8 SBACGKTUHB SBACGKTUHE SBACGKTUHG KIT, LIVER ANCILLARY PG40OTJ25 PG40OTJ26 PG40OTJ27 PG40OTJ28 PG40OTJUF LP 22GX3,5 ATRAUMATIC 26-LP4COA LP PEDIATRIC 22GX1,5 26-LP2COA LP TRAY 26-5090C 26-5090D 26-5090F 26-5090G 26-5090H 26-5090J 26-5090L LP TRAY ADULT 26-8426A 26-8426B 26-8426C LP TRAY ADULT DP 26-8425A LUMBAR PUNCTURE 20GX3 5 26-LP1COA LUMBAR PUNCTURE 20GX3 5 TRAY 26-9516A LUMBAR PUNCTURE TRAY 26-9516B 26-9516C LUMBAR PUNCTURE TRAY ADULT 26-7556D LUMBAR PUNCTURE W NDL DF 26-LP1CODA MSK PROCEDURE PACK SBA59MPIPD MYELOGRAM 22GX3 5 27-MY1COA MYELOGRAM 22GX3 5 ATRAUMATIC 27-MY2COA PACK LUMBAR PUNCTURE SBA30LBRMB PREP PACK PALI MOMI SBA55PPKCC PROCEDURE TRAY 27-2053A 27-2053B SAFE T PLUS MYELOGRAM TRAY 27-6209G SAFETY AMNIOCENTESIS 20GX3 5 29-AM1SFA SAFETY ARTHROGRAM TRAY 28-2677B 28-2677C 28-3208A 28-7483A 28-7483B 28-7483C SAFETY LP PEDIATRIC 22GX1 5 26-LP2SFA SAFETY LP PEDIATRIC KIT 26A9516A SAFETY LUMBAR PUNCTURE TRAY 26-2677D 26-2677E 26-2677F 26-7483A SAFETY MYELOGRAM 22GX3 5 27-MY1SFA SAFETY MYELOGRAM TRAY 26-3206A 27-2677A 27-2677B 27-2677C SAFETY PEDIATRIC LP TRAY 26-3207A 26-3207B 26-3207C SAFETY20G LUMBAR PUNCTURE TRAY 26-2677B 26-2677C 26-3205A 26-3205B 26-3205C SAFETY22G LUMBAR PUNCTURE TRAY 26-3208A SPECIAL PROCEDURE PACK SAN51SPJO2 SAN51SPJO4 SAN51SPJO5 SAN51SPJOA SBA43SPE11 SBA43SPEJD SBA43SPEJE SBA43SPEJF TUBE CHANGE PACK SANOCTCW19 ULTRASOUND TRAY SMA4AUSJHD US BIOPSY TRAY 32A9079J VEIN PACK SVA56VPI14 SVA56VPIVN
• Code Information: 29-AM1COA UDI-DI 10197106059630 Kit lots 510230 510527 511171 511560 513973 514111 514112 514209 514976 515451 515558 515943 516263 516264 516391 516501 517163 518670 519274 519427 519595 520323 520980 521113 521296 521297 521615 28-6325A UDI-DI 10198956426412 Kit lots 521404 522058 SBA53BSGR4 UDI-DI 10198956247963 Kit lot 651927 SBA53BSGRI UDI-DI 10888439608380 Kit lots 257202 313792 349006 375125 406359 423308 450452 469345 534068 601413 675881 679182 SNU12BSSAE UDI-DI 10888439614046 Kit lots 276592 406395 417945 446745 462215 465567 492238 515611 519946 547735 551819 559325 593317 623513 642512 758575 34A7423F UDI-DI 10197106151884 Kit lots 241134 267424 287349 314072 341007 34A7423G UDI-DI 10197106800478 Kit lots 376638 576864 585493 593628 622941 629402 633598 646882 683496 698131 SAN23LPDH4 UDI-DI 10197106987704 Kit lot 516068 SAN23LPDHA UDI-DI 10888439637151 Kit lots 509719 510519 510654 511190 511421 512321 512757 512975 513383 514405 514528 515705 515751 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Kit lot 520717 SAN23IAVA7 UDI-DI 10198956410800 Kit lot 520974 SAN23IAVAB UDI-DI 10195594873011 Kit lots 511522 511731 511829 512064 513000 513317 513504 513712 514337 514842 515190 516011 516292 516293 516559 517154 518980 SBACGKTU10 UDI-DI 10198956016033 Kit lot 483154 SBACGKTU11 UDI-DI 10198956036505 Kit lot 491775 SBACGKTU12 UDI-DI 10198956054196 Kit lot 500401 SBACGKTU13 UDI-DI 10198956107878 Kit lot 536839 SBACGKTU14 UDI-DI 10198956113671 Kit lot 544149 SBACGKTU15 UDI-DI 10198956165380 Kit lot 589210 SBACGKTU16 UDI-DI 10198956196124 Kit lot 613616 SBACGKTU17 UDI-DI 10198956209817 Kit lot 622981 SBACGKTU18 UDI-DI 10198956235748 Kit lot 643646 SBACGKTUH4 UDI-DI 10197106631164 Kit lot 251603 SBACGKTUH5 UDI-DI 10197106653869 Kit lot 267868 SBACGKTUH6 UDI-DI 10197106688069 Kit lot 291705 SBACGKTUH8 UDI-DI 10197106719091 Kit lot 312055 SBACGKTUHB UDI-DI 10197106271018 Kit lot 239979 SBACGKTUHE UDI-DI 10197106762882 Kit lots 402035 409113 SBACGKTUHG UDI-DI 10198956256842 Kit lots 662458 664353 667103 683070 753022 PG40OTJ25 UDI-DI 10197106647004 Kit lot 262474 PG40OTJ26 UDI-DI 10197106670088 Kit lot 279938 PG40OTJ27 UDI-DI 10197106716755 Kit lot 307490 PG40OTJ28 UDI-DI 10198956446175 Kit lot 763282 PG40OTJUF UDI-DI 10197106693018 Kit lot 346166 375580 393054 475121 490797 540057 633863 660229 689149 700313 26-LP4COA UDI-DI 10197106061725 Kit lots 509230 510754 511764 512507 513478 514198 515119 515470 515734 515826 516212 516403 516404 517161 517588 517589 517992 518588 519271 519368 519539 520183 520830 520831 521529 522140 26-LP2COA UDI-DI 10197106061763 Kit lots 509275 509828 509846 510550 510753 510860 511160 511199 512639 512803 513472 513497 513523 513524 513738 513739 513753 513777 513778 514078 514079 514228 514250 514508 514987 515121 515122 515168 515524 515556 515819 515856 516262 516354 516971 517191 518090 518262 518263 518312 519026 519027 519093 519109 519110 519111 519253 519254 519478 519717 519758 520137 520167 520372 520402 520478 520577 521274 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10197106735343 Kit lots 512718 513222 516036 516217 517397 517855 28-3208A UDI-DI 10195594883621 Kit lots 509669 510683 511094 511751 512195 512872 512960 513275 514041 514486 515177 515471 516389 519042 519959 521403 28-7483A UDI-DI 10197106022672 Kit lots 509772 510229 512147 512260 512365 516816 517557 28-7483B UDI-DI 10198956316126 Kit lots 520430 520591 28-7483C UDI-DI 10198956370173 Kit lot 521372 26-LP2SFA UDI-DI 10197106061756 Kit lots 509756 512708 513474 513499 514234 514425 514519 514991 515144 515145 515342 515801 516211 516326 516535 516590 516893 517047 517116 517117 517231 518757 518769 518802 518916 518917 519342 519463 519639 519652 519774 519856 519991 520828 520829 521210 521239 521256 521257 521289 521331 521346 521366 521623 522027 522028 26A9516A UDI-DI 10195594731168 Kit lots 510525 512146 513008 514074 514222 514393 514623 515361 515638 515802 516077 516455 517162 517395 519012 520384 520385 521012 521044 521097 521228 521279 26-2677D UDI-DI 10198956202269 Kit 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• 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: 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.