Device recalls

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

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

Open, ClassifiedNonconforming Material/ComponentZ-0216-2027
Open FDA's page for this record
Cfres ID
223219
Product res number
Z-0216-2027
Event date initiated
2026-09-24
Event date posted
2026-11-02
Recall status
Open, Classified
Res event number
100058
Product code
LRO
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
3702 units
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) 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.

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.

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
General Surgery Tray
Medical specialty description
General, Plastic Surgery
Regulation number
878.4370
Device class
2
K number
K952539, K934028, K951478, K872448, K934428, K892389, K964011, K950574, K930700, K871459, K951149, K920292, K895202, K932220, K914935, K890658, K963443, K874760, K213481, K890570, K883250, K914174, K923600, K880961, K932652, K882684, K873973, K914036, K931820, K935686, K893814, K871873, K964921, K931759, K932217, K931760, K945481, K874439, K925216, K902293 +70 more
Registration number
1030451, 3004111573, 3013600605, 3013502418, 3006540014, 3005841027, 1721686, 3011270181, 3011144486, 2024980, 3007139365, 1644019, 3004122598, 3009750712, 2431166, 1928237, 1055236, 3005391805, 8022032, 3006450239, 3005669815, 3031841433, 3017636737, 3004605321, 3030078769, 3014718111, 1823410, 3019798849, 3009637528, 2000028362, 3014325891, 9611024, 3007289408, 3012595397, 1650907, 3045816902, 1123137, 3035642068, 9611594, 1422634 +126 more
FEI number
1030451, 1000121355, 3004111573, 3013600605, 3013502418, 3006540014, 3002692512, 1721686, 3005841027, 3000718854, 3005596530, 3011270181, 3011144486, 1000514656, 3007139365, 1000306431, 3003040625, 3004122598, 3009750712, 1928237, 3005391805, 1000112877, 1000123297, 3005669815, 3031841433, 3006450239, 3017636737, 3004605321, 3030078769, 1823410, 3019798849, 3003807323, 3009637528, 2000028362, 3014325891, 1000512168, 3007289408, 3012595397, 3045816902, 3002807170 +126 more
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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.