Serious riskFDA DeviceClass I

Cardinal Health PBDS kits recalled for infusion set performance 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. The notice reports no injuries, and 15,247 kits are affected.

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 until you have contacted Cardinal Health.
  2. Check the catalog numbers and lot numbers listed in the notice, such as catalog MA3HD0326B, lot 331735, to identify affected kits.
  3. The notice doesn't specify a remedy; contact Cardinal Health for instructions on returns or replacements.

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) 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.
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 11 products — see all of them.

Details

Units affected
15247 kits
Illnesses reported
None reported
Manufactured in
3651 Birchwood Dr, Waukegan, Illinois, United States
Classification
Class I
Recall number
Z-0221-2027

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) 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. Kits contain infusion sets which were recalled for performance issues. 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; C
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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