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Class 1 Device Recall Cardinal Health Presource

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Class 1 Device Recall Cardinal Health Presource

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Date Initiated by Firm	September 24, 2026
Date Posted	November 02, 2026
Recall Status¹	Open³, Classified
Recall Number	Z-0213-2027
Recall Event ID	100058
Product Classification	Angiography/angioplasty kit - Product Code OEQ
Product	Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) STR CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVU3; 2) CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUN; 3) PACK CATH ANGIO PEDIATRIC , CATALOG #SAN68PAVUN; 4) STR CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUN; 5) STERILE PEDI EP PACK , CATALOG #SAN68PEVUL; 6) CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUM; 7) CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUM; 8) STR CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUM; 9) STRL CATH ANGIO PEDIATRIC PACK, CATALOG #SAN68PAVUM; 10) STR CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUL.
Code Information	CATALOG # SAN68PAVU3, GTIN 10887488679259 (ea) 50887488679257 (cs), LOT # 656037; CATALOG # SAN68PAVU3, GTIN 10887488679259 (ea) 50887488679257 (cs), LOT # 656037; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 430383; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 448702; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 505425; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 505425; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 505425; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 477816; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 477816; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 531638; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 545307; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 545307; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 562513; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 581000; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 608409; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 622834; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 622834; CATALOG # SAN68PEVUL, GTIN 10885425806676 (ea) 50885425806674 (cs), LOT # 535313; CATALOG # SAN68PEVUL, GTIN 10885425806676 (ea) 50885425806674 (cs), LOT # 560604; CATALOG # SAN68PEVUL, GTIN 10885425806676 (ea) 50885425806674 (cs), LOT # 590027; CATALOG # SAN68PEVUL, GTIN 10885425806676 (ea) 50885425806674 (cs), LOT # 628729; CATALOG # SAN68PEVUL, GTIN 10885425806676 (ea) 50885425806674 (cs), LOT # 651947; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 49750; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 160674; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 325840; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 74235; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 95459; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 129511; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 129511; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 166302; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 166302; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 190419; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 204448; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 247265; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 278921; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 308927; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 345699; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 362189; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 362189; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 384475; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 384475; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 384475; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 401874; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 412819; CATALOG # SAN68PAVUL, GTIN 885425806853 (ea) 50885425806858 (cs), LOT # 15617; CATALOG # SAN68PAVUL, GTIN 885425806853 (ea) 50885425806858 (cs), LOT # 27776; CATALOG # SAN68PAVUL, GTIN 885425806853 (ea) 50885425806858 (cs), LOT # 40547; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 18576; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 18576; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 43521; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 65296; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 103179; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 127075; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 159796; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 188985; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 223370; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 247415; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 247415; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 292705; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 335228; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 335228; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 347476; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 370316; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 370316; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 395956; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 421924; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 448620; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 488195; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 502293.
FEI Number	3001236905
Recalling Firm/ Manufacturer	Cardinal Health 200, LLC 3651 Birchwood Dr Waukegan IL 60085-8337
For Additional Information Contact	Cardinal Health Quality Systems 800-292-9332
Manufacturer Reason for Recall	Kits contain infusion sets which were recalled for performance issues.
FDA Determined Cause ²	Nonconforming Material/Component
Action	Cardinal Health issued an URGENT: MEDICAL DEVICE CORRECTION notice to its consignees on 9/24/2026 via US Mail. The notice explained the issue and requested the discontinuation of the use of the affected BD Alaris Pump Infusion Sets as per the enclosed notice from Becton Dickinson. The notice instructed the following: If you locate affected product within your facility, please do the following: 1. QUARANTINE affected kits. 2. ALERT your clinicians of this action. 3. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard the recalled component(s). 4. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648. Additional labels will be sent to your facility upon request. Please send an email to: gmb-FieldCorrectiveAction@cardinalhealth.com For component credit or replacement, please contact the following: Hospitals Cardinal Customer Service at 866.551.0533 Distributors Distributor Management at 800.635.6021 Federal Government facilities Government Customer Service at 800.444.1166 Distributors were directed to notify their customers of the recall. For questions contact: Cardinal Health Quality Systems at 800.292.9332.
Quantity in Commerce	3981 kits
Distribution	US and 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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