Cardinal Health Presource kits recalled for infusion set issues
Cardinal Health Presource PBDS kits contain BD Alaris Pump Infusion Sets, which were recalled for performance issues. The notice covers about 415,636 kits under many catalog numbers, labeled as labor, delivery, C-section, and other kits. No injuries have been reported, and the notice does not describe the specific failure.
From the FDA notice · Read the official notice ↗ · All Cardinal Health recalls
What to do
- Set aside kits matching the catalog and lot numbers listed in the notice, and do not use them.
- Identify affected kits by catalog number and lot number, such as catalog MA1DH7533C, lot 584713.
- The notice doesn't specify a remedy; contact Cardinal Health for next steps on return or replacement.
- Check the full product list in the notice, since it covers many 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) KIT, ANTEPARTUM IV , CATALOG # MA1DH7533C; 2) KIT, C SECTION , CATALOG # MAT4226716; 3) KIT, VAGINAL DELIVERY , CATALOG # MAT4226780; 4) KIT, CVR , CATALOG # OVCVM01028; 5) KIT, C SECTION , CATALOG # MAT4226715; 6) KIT, CVR , CATALOG # OVCVM01027; 7) KIT, VAGINAL DELIVERY , CATALOG # MAT4226714; 8) KIT, LABOR ADMISSION, , CATALOG # OROMH47346; 9) KIT, CVR , CATALOG # OVCVM01026; 10) KIT, VAGINAL DELIVERY , CATALOG # MAT4226779; 11) KIT, C SECTION , CATALOG # MAT4226713; 12) KIT, VAGINAL DELIVERY , CATALOG # MAT422677D; 13) KIT, VAGINAL DELIVERY , CATALOG # MAT4226778; 14) KIT, CVR , CATALOG # OVCVM01025; 15) KIT, C SECTION , CATALOG # MAT4226712; 16) KIT, CVR , CATALOG # OVCVM01024; 17) KIT, CVR , CATALOG # OVCVM01023; 18) KIT, CVR , CATALOG # OVCVM01022; 19) KIT, LABOR ADMISSION, , CATALOG # OROMH47345; 20) KIT, CVR , CATALOG # OVCVM01021; 21) KIT, CVR , CATALOG # SPKVM01018; 22) KIT, CVR , CATALOG # SPKVM01017; 23) KIT, CVR , CATALOG # SPKVM01016; 24) KIT, CVR , CATALOG # SPKVM01015; 25) KIT, CVR , CATALOG # SPKVM0102Z; 26) KIT, CVR , CATALOG # SPKVM01014; 27) KIT, LABOR ADMISSION, , CATALOG # OROMH47342; 28) KIT,MATERNAL TRANSPORT,, CATALOG # MA2JV8300C; 29) ANTEPARTUM IV, KIT , CATALOG # MA1DH7533B; 30) ANTEPARTUM IV, KIT , CATALOG # MA1DH7533A; 31) KIT, CVR , CATALOG # SPKVM0102Y; 32) KIT, CVR , CATALOG # SPKVM01013; 33) KIT, CVR , CATALOG # SPKVM01012; 34) KIT,MATERNAL TRANSPORT,, CATALOG # MA2JV8300B; 35) LABOR ADMISSIONS, KIT , CATALOG # MATOC03267; 36) LABOR ADMISSIONS, KIT , CATALOG # MATOC0326E; 37) LABOR ADMISSIONS, KIT , CATALOG # MATV12514B; 38) LABOR ADMISSIONS, KIT , CATALOG # MATOC03266; 39) LABOR ADMISSIONS, KIT , CATALOG # MATV125141; 40) LABOR ADMISSIONS, KIT , CATALOG # MATOC03265; 41) KIT, LABOR ADMISSIONS , CATALOG # MATV12514A; 42) KIT,MATERNAL TRANSPORT,, CATALOG # MA2JV8300A; 43) KIT,IV START, , CATALOG # IVSJV8300A; 44) KIT, LABOR ADMISSION, , CATALOG # OROMH4734G; 45) KIT, LABOR ADMISSION, , CATALOG # OROMH4734G; 46) KIT, GI LOCAL ADMIT , CATALOG # SPKJV8300D; 47) KIT EMERGENCY BASKET GENERAL , CATALOG # RES3077323; 48) KIT EMERGENCY BASKET GENERAL , CATALOG # RES3077322; 49) KIT EMERGENCY BASKET GENERAL , CATALOG # RES3077321; 50) KIT, C SECTION , CATALOG # MAT4226724; 51) KIT, VAGINAL DELIVERY , CATALOG # MAT4226790; 52) KIT, VAGINAL DELIVERY , CATALOG # MAT4226789; 53) KIT, VAGINAL DELIVERY , CATALOG # MAT4226788; 54) KIT, VAGINAL DELIVERY , CATALOG # MAT422677F; 55) KIT, C SECTION , CATALOG # MAT42267AK; 56) KIT, CVR , CATALOG # OVCVM01040; 57) KIT, CVR , CATALOG # OVCVM01039; 58) KIT, VAGINAL DELIVERY , CATALOG # MAT422677E; 59) KIT, CVR , CATALOG # OVCVM01038; 60) KIT, VAGINAL DELIVERY , CATALOG # MAT4226787; 61) KIT, C SECTION , CATALOG # MAT42267AJ; 62) KIT, C SECTION , CATALOG # MAT4226723; 63) KIT, VAGINAL DELIVERY , CATALOG # MAT4226786; 64) KIT, C SECTION , CATALOG # MAT4226722; 65) KIT, VAGINAL DELIVERY , CATALOG # MAT4226785; 66) KIT, CVR , CATALOG # OVCVM01037; 67) KIT, C SECTION
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
This recall covers 11 products — see all of them.
Details
- Units affected
- 415636 kits
- Illnesses reported
- None reported
- Manufactured in
- 3651 Birchwood Dr, Waukegan, Illinois, United States
- Classification
- Class I
- Recall number
- Z-0217-2027
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, ANTEPARTUM IV , CATALOG # MA1DH7533C; 2) KIT, C SECTION , CATALOG # MAT4226716; 3) KIT, VAGINAL DELIVERY , CATALOG # MAT4226780; 4) KIT, CVR , CATALOG # OVCVM01028; 5) KIT, C SECTION , CATALOG # MAT4226715; 6) KIT, CVR , CATALOG # OVCVM01027; 7) KIT, VAGINAL DELIVERY , CATALOG # MAT4226714; 8) KIT, LABOR ADMISSION, , CATALOG # OROMH47346; 9) KIT, CVR , CATALOG # OVCVM01026; 10) KIT, VAGINAL DELIVERY , CATALOG # MAT4226779; 11) KIT, C SECTION , CATALOG # MAT4226713; 12) KIT, VAGINAL DELIVERY , CATALOG # MAT422677D; 13) KIT, VAGINAL DELIVERY , CATALOG # MAT4226778; 14) KIT, CVR , CATALOG # OVCVM01025; 15) KIT, C SECTION , CATALOG # MAT4226712; 16) KIT, CVR , CATALOG # OVCVM01024; 17) KIT, CVR , CATALOG # OVCVM01023; 18) KIT, CVR , CATALOG # OVCVM01022; 19) KIT, LABOR ADMISSION, , CATALOG # OROMH47345; 20) KIT, CVR , CATALOG # OVCVM01021; 21) KIT, CVR , CATALOG # SPKVM01018; 22) KIT, CVR , CATALOG # SPKVM01017; 23) KIT, CVR , CATALOG # SPKVM01016; 24) KIT, CVR , CATALOG # SPKVM01015; 25) KIT, CVR , CATALOG # SPKVM0102Z; 26) KIT, CVR , CATALOG # SPKVM01014; 27) KIT, LABOR ADMISSION, , CATALOG # OROMH47342; 28) KIT,MATERNAL TRANSPORT,, CATALOG # MA2JV8300C; 29) ANTEPARTUM IV, KIT , CATALOG # MA1DH7533B; 30) ANTEPARTUM IV, KIT , CATALOG # MA1DH7533A; 31) KIT, CVR , CATALOG # SPKVM0102Y; 32) KIT, CVR , CATALOG # SPKVM01013; 33) KIT, CVR , CATALOG # SPKVM01012; 34) KIT,MATERNAL TRANSPORT,, CATALOG # MA2JV8300B; 35) LABOR ADMISSIONS, KIT , CATALOG # MATOC03267; 36) LABOR ADMISSIONS, KIT , CATALOG # MATOC0326E; 37) LABOR ADMISSIONS, KIT , CATALOG # MATV12514B; 38) LABOR ADMISSIONS, KIT , CATALOG # MATOC03266; 39) LABOR ADMISSIONS, KIT , CATALOG # MATV125141; 40) LABOR ADMISSIONS, KIT , CATALOG # MATOC03265; 41) KIT, LABOR ADMISSIONS , CATALOG # MATV12514A; 42) KIT,MATERNAL TRANSPORT,, CATALOG # MA2JV8300A; 43) KIT,IV START, , CATALOG # IVSJV8300A; 44) KIT, LABOR ADMISSION, , CATALOG # OROMH4734G; 45) KIT, LABOR ADMISSION, , CATALOG # OROMH4734G; 46) KIT, GI LOCAL ADMIT , CATALOG # SPKJV8300D; 47) KIT EMERGENCY BASKET GENERAL , CATALOG # RES3077323; 48) KIT EMERGENCY BASKET GENERAL , CATALOG # RES3077322; 49) KIT EMERGENCY BASKET GENERAL , CATALOG # RES3077321; 50) KIT, C SECTION , CATALOG # MAT4226724; 51) KIT, VAGINAL DELIVERY , CATALOG # MAT4226790; 52) KIT, VAGINAL DELIVERY , CATALOG # MAT4226789; 53) KIT, VAGINAL DELIVERY , CATALOG # MAT4226788; 54) KIT, VAGINAL DELIVERY , CATALOG # MAT422677F; 55) KIT, C SECTION , CATALOG # MAT42267AK; 56) KIT, CVR , CATALOG # OVCVM01040; 57) KIT, CVR , CATALOG # OVCVM01039; 58) KIT, VAGINAL DELIVERY , CATALOG # MAT422677E; 59) KIT, CVR , CATALOG # OVCVM01038; 60) KIT, VAGINAL DELIVERY , CATALOG # MAT4226787; 61) KIT, C SECTION , CATALOG # MAT42267AJ; 62) KIT, C SECTION , CATALOG # MAT4226723; 63) KIT, VAGINAL DELIVERY , CATALOG # MAT4226786; 64) KIT, C SECTION , CATALOG # MAT4226722; 65) KIT, VAGINAL DELIVERY , CATALOG # MAT4226785; 66) KIT, CVR , CATALOG # OVCVM01037; 67) KIT, C SECTION Kits contain infusion sets which were recalled for performance issues. CATALOG #MA1DH7533C, GTIN 10888439997057 (ea) 50888439997055 (cs), LOT # 584713; CATALOG #MA1DH7533C, GTIN 10888439997057 (ea) 50888439997055 (cs), LOT # 584713; CATALOG #MA1DH7533C, GTIN 10888439997057 (ea) 50888439997055 (cs), LOT # 584713; CATALOG #MA1DH7533C, GTIN 10888439997057 (ea) 50888439997055 (cs), LOT # 584713; CATALOG #MA1DH7533C, GTIN 10888439997057 (ea) 50888439997055 (cs), LOT # 585725; CATALOG #MA1DH7533C, GTIN 10888439997057 (ea) 50888439997055 (cs), LOT # 585725; CATALOG #MA1DH7533C, GTIN 10888439997057 (ea) 50888439997055 (cs), LOT # 585725; CATALOG #MAT4226716, GTIN 10888439989779 (ea) 50888439989777 (cs), LOT # 554018; CATALOG #MAT4226780, GTIN 10888439986112 (ea) 50888439986110 (cs), LOT # 551641; CATALOG #MAT4226780, GTIN 10888439986112 (ea) 50888439986110 (cs), LOT # 551641; CATALOG #MAT4226780, GTIN 10888439986112 (ea) 50888439986110 (cs), LOT # 551641; CATALOG #MAT4226780, GTIN 1088
- 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.
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) KIT, ANESTHESIA, CA…Z-0212-2027 · 12358 kits
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) STR CATH ANGIO PEDI…Z-0213-2027 · 3981 kits
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: KIT, CATH LAB ADMIT, CA…Z-0214-2027 · 30 kits
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) KIT, CABG,…Z-0215-2027 · 21429 units
- 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 ADMI…Z-0216-2027 · 3702 units
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) KIT, ANTEPARTUM IV… (this page)Z-0217-2027 · 415636 kits
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) IV START LD KIT…Z-0218-2027 · 221554 kits
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: SWAN GANZ, KIT, CATALOG…Z-0219-2027 · 112 kits
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) KIT,LABOR KIT,…Z-0220-2027 · 47707 kits
- 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, KI…Z-0221-2027 · 15247 kits
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: KIT EMERGENCY BASKET GE…Z-0222-2027 · 48 kits
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