Device recall

Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) C SECTION, ADM, KIT , CATALOG #MA3HD0326B; 2) C SECTION, ADM, KIT , CATALOG #MA3HD03263; 3) C SECTION, ADM, KIT , CATALOG #MA1V125141; 4) C SECTION, ADM, KIT , CATALOG #MA3HD03262; 5) C SECTION, ADM ,KIT , CATALOG #MA3HD03261; 6) KIT,C SECTION ADMIT, , CATALOG #MATJV8300B; 7) C SECTION, ADM, KIT , CATALOG #MA1V12514A; 8) KIT, C SECTION, ADM , CATALOG #MA1V12514A; 9) KIT,C SECTION ADMIT, , CATALOG #MATJV8300A; 10) C SECTION, ADMISSION KIT , CATALOG #PLHDCAHC2; 11) C SECTION, ADMISSION ,KIT , CATALOG #PLHDCAHCO; 12) C SECTION, ADMISSION KIT , CATALOG #PLHDCAHC1; 13) KIT,C SECTION ADMIT, , CATALOG #PZJVADMMX; 14) KIT,C SECTION ADMIT,, CATALOG #PZJVADMMW; 15) C SECTION ADMIT,KIT, CATALOG #PZJVADMMV; 16) C SECTION, ADMISSION KIT , CATALOG #PLHDCAHCP; 17) C SECTION, ADM KIT , CATALOG #MA3HD0326A; 18) C SECTION, ADM, KIT , CATALOG #MA3HD0326A; 19) KIT, C SECTION, ADM , CATALOG #MA3HD0326A.

FDA recall source

Recall number

Z-0221-2027

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

OHM

Device type

Cesarean Section Tray

Reason

Kits contain infusion sets which were recalled for performance issues.

Root cause

Nonconforming Material/Component

Quantity

15247 kits

Code info

CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 331735; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 331735; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 339023; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 339023; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 341402; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 341402; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 341402; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 351145; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 351145; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 351145; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 356177; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 356177; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 356177; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 361881; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 361881; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 361881; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 361881; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 369350; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 369350; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 375879; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 375879; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 375879; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 381100; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 381117; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 381117; CATALOG # MA3HD0326B, GTIN 10887488229751 (ea) 50887488229759 (cs), Lot # 381117; CATALOG # MA3HD03263, GTIN 10887488224343 (ea) 50887488224341 (cs), Lot # 326029; CATALOG # MA3HD03263, GTIN 10887488224343 (ea) 50887488224341 (cs), Lot # 326029; CATALOG # MA3HD03263, GTIN 10887488224343 (ea) 50887488224341 (cs), Lot # 326029; CATALOG # MA1V125141, GTIN 10887488212074 (ea) 50887488212072 (cs), Lot # 323763; CATALOG # MA3HD03262, GTIN 10887488181394 (ea) 50887488181392 (cs), Lot # 317367; CATALOG # MA3HD03262, GTIN 10887488181394 (ea) 50887488181392 (cs), Lot # 317367; CATALOG # MA3HD03261, GTIN 10887488178172 (ea) 50887488178170 (cs), Lot # 315984; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 263376; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 295952; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 316164; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 316164; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 332772; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 332772; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 345148; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 345148; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 345148; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 365913; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 376327; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 376327; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 398577; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 398577; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 398577; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 418270; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 418270; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 442158; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 445625; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 445625; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 445625; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 487330; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 487330; CATALOG # MATJV8300B, GTIN 10887488138411 (ea) 50887488138419 (cs), Lot # 479198; CATALOG # MA1V12514A, GTIN 10887488134222 (ea) 50887488134220 (cs), Lot # 322269; CATALOG # MA1V12514A, GTIN 10887488134222 (ea) 50887488134220 (cs), Lot # 310120; CATALOG # MATJV8300A, GTIN 10887488061665 (ea) 50887488061663 (cs), Lot # 221039; CATALOG # MATJV8300A, GTIN 10887488061665 (ea) 50887488061663 (cs), Lot # 221039; CATALOG # MATJV8300A, GTIN 10887488061665 (ea) 50887488061663 (cs), Lot # 221039; CATALOG # MATJV8300A, GTIN 10887488061665 (ea) 50887488061663 (cs), Lot # 230037; CATALOG # MATJV8300A, GTIN 10887488061665 (ea) 50887488061663 (cs), Lot # 230037; CATALOG # MATJV8300A, GTIN 10887488061665 (ea) 50887488061663 (cs), Lot # 240709; CATALOG # MATJV8300A, GTIN 10887488061665 (ea) 50887488061663 (cs), Lot # 240709; CATALOG # PLHDCAHC2, GTIN 8854251476976 (ea) 58854251476971 (cs), Lot # 117230; CATALOG # PLHDCAHCO, GTIN 8854251476297 (ea) 58854251476292 (cs), Lot # 126959; CATALOG # PLHDCAHCO, GTIN 8854251476297 (ea) 58854251476292 (cs), Lot # 126959; CATALOG # PLHDCAHCO, GTIN 8854251476297 (ea) 58854251476292 (cs), Lot # 131445; CATALOG # PLHDCAHCO, GTIN 8854251476297 (ea) 58854251476292 (cs), Lot # 131445; CATALOG # PLHDCAHCO, GTIN 8854251476297 (ea) 58854251476292 (cs), Lot # 131445; CATALOG # PLHDCAHCO, GTIN 8854251476297 (ea) 58854251476292 (cs), Lot # 131445; CATALOG # PLHDCAHCO, GTIN 8854251476297 (ea) 58854251476292 (cs), Lot # 131445; CATALOG # PLHDCAHC1, GTIN 8854251374395 (ea) 58854251374390 (cs), Lot # 87291; CATALOG # PZJVADMMX, GTIN 885425888354 (ea) 50885425888359 (cs), Lot # 70960; CATALOG # PZJVADMMX, GTIN 885425888354 (ea) 50885425888359 (cs), Lot # 85735; CATALOG # PZJVADMMX, GTIN 885425888354 (ea) 50885425888359 (cs), Lot # 100525; CATALOG # PZJVADMMX, GTIN 885425888354 (ea) 50885425888359 (cs), Lot # 118988; CATALOG # PZJVADMMX, GTIN 885425888354 (ea) 50885425888359 (cs), Lot # 143949; CATALOG # PZJVADMMX, GTIN 885425888354 (ea) 50885425888359 (cs), Lot # 153492; CATALOG # PZJVADMMX, GTIN 885425888354 (ea) 50885425888359 (cs), Lot # 153492; CATALOG # PZJVADMMX, GTIN 885425888354 (ea) 50885425888359 (cs), Lot # 196575; CATALOG # PZJVADMMX, GTIN 885425888354 (ea) 50885425888359 (cs), Lot # 196575; CATALOG # PZJVADMMW, GTIN 885425805870 (ea) 50885425805875 (cs), Lot # 24192; CATALOG # PZJVADMMW, GTIN 885425805870 (ea) 50885425805875 (cs), Lot # 27725; CATALOG # PZJVADMMW, GTIN 885425805870 (ea) 50885425805875 (cs), Lot # 38222; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 85448; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 99679; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 121945; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 131165; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 131165; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 131165; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 131165; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 140773; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 150991; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 150991; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 158662; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 158662; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 166757; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 175359; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 175359; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 186278; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 186278; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 186278; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 190944; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 190944; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 190944; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 196571; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 196571; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 204012; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 204012; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 204012; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 204012; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 204012; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 204012; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 214000; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 214000; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 222855; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 222855; CATALOG # PZJVADMMV, GTIN 885425236384 (ea) 50885425236389 (cs), Lot # 222855; CATALOG # PLHDCAHCP, GTIN 885425223544 (ea) 50885425223549 (cs), Lot # 141935; CATALOG # PLHDCAHCP, GTIN 885425223544 (ea) 50885425223549 (cs), Lot # 141935; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 89795; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 117696; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 117696; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 117696; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 117696; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 132065; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 132065; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 138323; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 142458; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 147779; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 152213; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 156746; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 156746; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 162582; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 165381; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 168556; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 170469; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 175132; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 175132; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 175132; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 175132; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 175132; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 262725; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 262725; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 267881; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 267881; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 274948; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 279734; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 286196; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 286196; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 294184; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 294184; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 294184; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 298007; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 298007; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 298007; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 306961; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 309779; CATALOG # MA3HD0326A, GTIN 885425110646 (ea) 50885425110641 (cs), Lot # 309779.

Distribution

US and Canada

Location

Waukegan, IL