Device recalls

Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) STR…

Cardinal Health 200, LLC · Kits contain infusion sets which were recalled for performance issues.

Open, ClassifiedNonconforming Material/ComponentZ-0213-2027
Open FDA's page for this record
Cfres ID
223216
Product res number
Z-0213-2027
Event date initiated
2026-09-24
Event date posted
2026-11-02
Recall status
Open, Classified
Res event number
100058
Product code
OEQ
Firm FEI number
3001236905
Recalling firm
Cardinal Health 200, LLC
Address 1
3651 Birchwood Dr
City
Waukegan
State
IL
Postal code
60085-8337
Additional info contact
Cardinal Health Quality Systems 800-292-9332
Reason for recall
Kits contain infusion sets which were recalled for performance issues.
Root cause description
Nonconforming Material/Component
Product quantity
3981 kits
Distribution pattern
US and Canada
Product description

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 info

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.

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.

Harmonized identifiers (openFDA)
Device name
Angiography/Angioplasty Kit
Medical specialty description
Cardiovascular
Regulation number
870.1650
Device class
2
Registration number
2030624, 1061124, 3025346039, 3008513424, 1721504, 1030451, 3012964172, 3004111573, 1054241, 3005595283, 1319639, 3014925393, 3011642792, 3002834291, 1423395, 2320762, 1625425, 3015225571, 3004122598, 3009888344, 1018470, 3012536737, 1047429, 3015173212, 3007329020, 1928237, 1043214, 1055236, 9616662, 1724474, 1643817, 2029015, 3015910259, 3004605321, 3045816907, 1125782, 1721676, 3002807314, 3005012805, 3004911384 +13 more
FEI number
3025346039, 3008513424, 1721504, 1030451, 3012964172, 3004111573, 1000112968, 3005595283, 3014925393, 3002902735, 3011642792, 3002834291, 1000514656, 1625425, 1000138054, 3015225571, 3003040625, 3004122598, 3000335778, 3009888344, 1018470, 3012536737, 1047429, 3015173212, 3007329020, 1928237, 1043214, 1000112877, 1643817, 3001236905, 3002975287, 3015910259, 3004605321, 3045816907, 3003094851, 1721676, 3002807314, 3005012805, 1000512168, 3007289408 +13 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.