Device recall

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.

FDA recall source

Recall number

Z-0213-2027

Event id

100058

Status

Open, Classified

FDA classification

Class II

Recalling firm

Cardinal Health 200, LLC

Posted

Nov 2, 2026

Initiated

Sep 24, 2026

Product code

OEQ

Device type

Angiography/Angioplasty Kit

Reason

Kits contain infusion sets which were recalled for performance issues.

Root cause

Nonconforming Material/Component

Quantity

3981 kits

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.

Distribution

US and Canada

Location

Waukegan, IL