Z-0216-2027

Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module...

Name: Z-0216-2027 Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module...
Creator: Cardinal Health 200, LLC
Published: 2026-09-24
License: https://open.fda.gov/license/

Cardinal Health 200, LLC / initiated 2026-09-24 / Open, Classified

FDA source

Recall record

Recall number: Z-0216-2027
Status: Open, Classified
Initiated: 2026-09-24
Posted: 2026-11-02
Recalling firm: Cardinal Health 200, LLC
Product: 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.
Product code: LRO General Surgery Tray
Reason for recall: Kits contain infusion sets which were recalled for performance issues.
FDA root cause: Nonconforming Material/Component
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: [email protected] 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.
Quantity in commerce: 3702 units
Distribution: US and Canada
Product codes and lots: 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.

Product code LRO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-28, the FDA export date for this dataset. Page last changed 2026-11-06. View this recall on fda.gov (opens on fda.gov)