Device recall

Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: 1) KIT,C SECTION ADMIT,, CATALOG # MATJV8300D; 2) KIT,C SECTION ADMIT,, CATALOG # MATJV8300C; 3) KIT, EMERGENCY C SECTION ADMIT, CATALOG # MAT216337B; 4) IN PATIENT KIT , CATALOG # PG21OTAUHA.

FDA recall source

Recall number

Z-0216-2027

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

LRO

Device type

General Surgery Tray

Reason

Kits contain infusion sets which were recalled for performance issues.

Root cause

Nonconforming Material/Component

Quantity

3702 units

Code info

CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 714910; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 714910; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 714910; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 751344; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 751344; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 777503; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 777503; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 777503; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 798883; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 798883; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 814260; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 814260; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 828593; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 840520; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 866612; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 866612; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 866612; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 893976; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 893976; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 893976; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 913992; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 913992; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 927459; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 927459; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 939058; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 939058; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 962269; CATALOG # MATJV8300D, GTIN 10887488724942 (ea) 50887488724940 (cs), LOT # 962269; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 506956; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 506956; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 514741; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 551732; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 563298; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 563298; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 579488; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 579488; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 595128; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 611300; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 611300; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 611300; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 611300; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 636464; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 636464; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 636464; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 660250; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 660250; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 660250; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 660250; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 660250; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 686418; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 686418; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 686418; CATALOG # MATJV8300C, GTIN 10887488483139 (ea) 50887488483137 (cs), LOT # 686418; CATALOG # MAT216337B, GTIN 10195594599317 (ea) 50195594599315 (cs), LOT # 821524; CATALOG # MAT216337B, GTIN 10195594599317 (ea) 50195594599315 (cs), LOT # 821524; CATALOG # PG21OTAUHA, GTIN 382603208374 (ea) 50382603208379 (cs), LOT # 808300; CATALOG # PG21OTAUHA, GTIN 382603208374 (ea) 50382603208379 (cs), LOT # 808300; CATALOG # PG21OTAUHA, GTIN 382603208374 (ea) 50382603208379 (cs), LOT # 808300; CATALOG # PG21OTAUHA, GTIN 382603208374 (ea) 50382603208379 (cs), LOT # 808300.

Distribution

US and Canada

Location

Waukegan, IL