Serious riskFDA DeviceClass I

Cardinal Health Presource kits recalled for infusion set issues

Cardinal Health Presource PBDS kits containing BD Alaris Pump Infusion Sets, used with the BD Alaris Pump Module Model 8100, are being recalled. The kits contain infusion sets that were recalled for performance issues. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Cardinal Health recalls

What to do

  1. Set aside affected kits and do not use them with the BD Alaris Pump Module Model 8100.
  2. Check catalog numbers MATJV8300D, MATJV8300C, MAT216337B, and PG21OTAUHA, and compare the GTIN and lot numbers on the packaging with the lists in the notice.
  3. The notice does not specify a remedy; contact Cardinal Health for instructions on the affected kits.

Is yours affected?

Compare your label or packaging with the recalled product.

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.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 11 products — see all of them.

Details

Units affected
3702 units
Illnesses reported
None reported
Manufactured in
3651 Birchwood Dr, Waukegan, Illinois, United States
Classification
Class I
Recall number
Z-0216-2027

In the FDA's words

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. Kits contain infusion sets which were recalled for performance issues. 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, GTI
Hazard
Kits contain infusion sets which were recalled for performance issues.

11 products in this recall

Cardinal Health Presource kits recalled for infusion set issues

FDA classified this as a Class I recall of 11 Cardinal Health Presource PBDS kits, distributed in the US and Canada. Each kit contains BD Alaris Pump Infusion Sets for use with the BD Alaris Pump Module Model 8100, and the infusion sets were recalled for performance issues. The kits are labeled with names such as anesthesia, cath lab, C-section, labor, and emergency kits. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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