Serious riskFDA DeviceClass I

Cardinal Health Presource kits recalled for pump infusion set issue

Cardinal Health is recalling about 30,137 Presource PBDS kits that contain BD Alaris Pump Infusion Sets for use with the BD Alaris Pump Module Model 8100. The notice describes the reason only as a notification of performance disclosures of a kit component, and the FDA has classified it as Class I. No injuries have been reported.

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

What to do

  1. Contact Cardinal Health and your clinical team before using any affected kit.
  2. Check the catalog numbers, GTINs, and WO numbers in the notice, such as catalog MAT232105E (GTIN 10887488366999), against the kits you have.
  3. The notice doesn't state a remedy; ask Cardinal Health how to return or replace affected kits.
  4. Check the full list in the notice, which covers 40 labeled kit catalog numbers.

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) LDR,MUSC,KIT , CATALOG # MAT232105E; 2) LDR,MUSC,KIT , CATALOG # MAT232105F; 3) C SECTION ADMIT,KIT , CATALOG # MA1232105E; 4) KIT,NICU ADMIT, , CATALOG # BABMH5297F; 5) KIT,NICU ADMIT, , CATALOG # BABMH5297G; 6) KIT,NICU ADMIT, , CATALOG # BABMH5297H; 7) KIT,NICU ADMIT, , CATALOG # BABMH5297I; 8) KIT,NICU ADMIT, , CATALOG # BABMH52971; 9) KIT,NICU ADMIT, , CATALOG # BABMH52972; 10) KIT,OPEN HEART ANESTHESIA , CATALOG # PC4KOHSCD; 11) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCE; 12) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCF; 13) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCG; 14) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC2; 15) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC4; 16) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC5; 17) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC6; 18) OPEN HEART ANESTHESIA, , CATALOG # PC4KOHSC7; 19) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC8; 20) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC9; 21) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS10; 22) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS11; 23) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS12; 24) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS13; 25) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS14; 26) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS15; 27) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS16; 28) NICU ADMIT, KIT , CATALOG # BABMH5297E; 29) NICU ADMIT, KIT , CATALOG # BABMH5297F; 30) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCA; 31) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCB; 32) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCC; 33) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCD; 34) OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCE; 35) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSC1; 36) SPECIAL PROCEDURE KIT , CATALOG # SP1410346C; 37) SPECIAL PROCEDURE KIT , CATALOG # SP14103461; 38) SPECIAL PROCEDURE KIT , CATALOG # SP14103462; 39) SPECIAL PROCEDURE KIT , CATALOG # SP14103463; 40) SPECIAL PROCEDURE KIT , CATALOG # SP14103464.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 2 products — see all of them.

Details

Units affected
30137 kits
Illnesses reported
None reported
Manufactured in
3651 Birchwood Dr, Waukegan, Illinois, United States
Classification
Class I
Recall number
Z-0330-2027

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) LDR,MUSC,KIT , CATALOG # MAT232105E; 2) LDR,MUSC,KIT , CATALOG # MAT232105F; 3) C SECTION ADMIT,KIT , CATALOG # MA1232105E; 4) KIT,NICU ADMIT, , CATALOG # BABMH5297F; 5) KIT,NICU ADMIT, , CATALOG # BABMH5297G; 6) KIT,NICU ADMIT, , CATALOG # BABMH5297H; 7) KIT,NICU ADMIT, , CATALOG # BABMH5297I; 8) KIT,NICU ADMIT, , CATALOG # BABMH52971; 9) KIT,NICU ADMIT, , CATALOG # BABMH52972; 10) KIT,OPEN HEART ANESTHESIA , CATALOG # PC4KOHSCD; 11) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCE; 12) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCF; 13) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCG; 14) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC2; 15) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC4; 16) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC5; 17) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC6; 18) OPEN HEART ANESTHESIA, , CATALOG # PC4KOHSC7; 19) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC8; 20) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSC9; 21) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS10; 22) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS11; 23) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS12; 24) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS13; 25) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS14; 26) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS15; 27) KIT,OPEN HEART ANESTHESIA,, CATALOG # PC4KOHS16; 28) NICU ADMIT, KIT , CATALOG # BABMH5297E; 29) NICU ADMIT, KIT , CATALOG # BABMH5297F; 30) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCA; 31) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCB; 32) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCC; 33) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSCD; 34) OPEN HEART ANESTHESIA,, CATALOG # PC4KOHSCE; 35) OPEN HEART ANESTHESIA KIT , CATALOG # PC4KOHSC1; 36) SPECIAL PROCEDURE KIT , CATALOG # SP1410346C; 37) SPECIAL PROCEDURE KIT , CATALOG # SP14103461; 38) SPECIAL PROCEDURE KIT , CATALOG # SP14103462; 39) SPECIAL PROCEDURE KIT , CATALOG # SP14103463; 40) SPECIAL PROCEDURE KIT , CATALOG # SP14103464. Notification of performance disclosures of kit component. CATALOG # MAT232105E, GTIN 10887488366999 (ea) 50887488366997 (cs), WO # MAT232105E; CATALOG # MAT232105E, GTIN 10887488366999 (ea) 50887488366997 (cs), WO # MAT232105E; CATALOG # MAT232105E, GTIN 10887488366999 (ea) 50887488366997 (cs), WO # MAT232105E; CATALOG # MAT232105E, GTIN 10887488366999 (ea) 50887488366997 (cs), WO # MAT232105E; CATALOG # MAT232105E, GTIN 10887488366999 (ea) 50887488366997 (cs), WO # MAT232105E; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea) 50887488443391 (cs), WO # MAT232105F; CATALOG # MAT232105F, GTIN 10887488443393 (ea)
Hazard
Notification of performance disclosures of kit component.

2 products in this recall

Cardinal Health Presource kits recalled for performance disclosures

Cardinal Health is recalling 2 Presource PBDS kits that contain BD Alaris Pump Infusion Sets for use with the BD Alaris Pump Module Model 8100. The kits are labeled Open Heart A,B,C (9,571 units) and LDR,MUSC,KIT (30,137 kits), and were sent to CA, TX and NC. The FDA classifies this as Class I, and the notice describes performance disclosures of a kit component; no injuries have been reported.

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

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