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 kits are labeled as pediatric angiography packs and are used with the BD Alaris Pump Module Model 8100. About 3,981 kits are affected, and no injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Cardinal Health recalls
What to do
- Remove affected kits from use and set aside any with the catalog and lot numbers listed in the notice.
- Identify affected kits by catalog numbers SAN68PAVU3, SAN68PAVUN, SAN68PEVUL, SAN68PAVUM, and SAN68PAVUL, with the GTINs and lot numbers in the notice.
- The notice does not state a remedy; contact Cardinal Health 200, LLC for next steps.
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) STR CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVU3; 2) CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUN; 3) PACK CATH ANGIO PEDIATRIC , CATALOG #SAN68PAVUN; 4) STR CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUN; 5) STERILE PEDI EP PACK , CATALOG #SAN68PEVUL; 6) CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUM; 7) CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUM; 8) STR CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUM; 9) STRL CATH ANGIO PEDIATRIC PACK, CATALOG #SAN68PAVUM; 10) STR CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUL.
- Sold in
- Nationwide
- Made for
- Children (under 18 years)
This recall covers 11 products — see all of them.
Details
- Units affected
- 3981 kits
- Illnesses reported
- None reported
- Manufactured in
- 3651 Birchwood Dr, Waukegan, Illinois, United States
- Classification
- Class I
- Recall number
- Z-0213-2027
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) STR CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVU3; 2) CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUN; 3) PACK CATH ANGIO PEDIATRIC , CATALOG #SAN68PAVUN; 4) STR CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUN; 5) STERILE PEDI EP PACK , CATALOG #SAN68PEVUL; 6) CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUM; 7) CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUM; 8) STR CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUM; 9) STRL CATH ANGIO PEDIATRIC PACK, CATALOG #SAN68PAVUM; 10) STR CATH ANGIO PEDIATRIC PACK , CATALOG #SAN68PAVUL. Kits contain infusion sets which were recalled for performance issues. CATALOG # SAN68PAVU3, GTIN 10887488679259 (ea) 50887488679257 (cs), LOT # 656037; CATALOG # SAN68PAVU3, GTIN 10887488679259 (ea) 50887488679257 (cs), LOT # 656037; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 430383; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 448702; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 505425; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 505425; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 505425; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 477816; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 477816; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 531638; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 545307; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 545307; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 562513; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 581000; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 608409; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 622834; CATALOG # SAN68PAVUN, GTIN 10887488340357 (ea) 50887488340355 (cs), LOT # 622834; CATALOG # SAN68PEVUL, GTIN 10885425806676 (ea) 50885425806674 (cs), LOT # 535313; CATALOG # SAN68PEVUL, GTIN 10885425806676 (ea) 50885425806674 (cs), LOT # 560604; CATALOG # SAN68PEVUL, GTIN 10885425806676 (ea) 50885425806674 (cs), LOT # 590027; CATALOG # SAN68PEVUL, GTIN 10885425806676 (ea) 50885425806674 (cs), LOT # 628729; CATALOG # SAN68PEVUL, GTIN 10885425806676 (ea) 50885425806674 (cs), LOT # 651947; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 49750; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 160674; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 325840; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 74235; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 95459; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 129511; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 129511; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 166302; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 166302; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 190419; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 204448; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 247265; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 278921; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 308927; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 345699; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 362189; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 362189; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 384475; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 384475; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 384475; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 401874; CATALOG # SAN68PAVUM, GTIN 885425857893 (ea) 50885425857898 (cs), LOT # 412819; CATALOG # SAN68PAVUL, GTIN 885425806853 (ea) 50885425806858 (cs), LOT # 15617; CATALOG # SAN68PAVUL, GTIN 885425806853 (ea) 50885425806858 (cs), LOT # 27776; CATALOG # SAN68PAVUL, GTIN 885425806853 (ea) 50885425806858 (cs), LOT # 40547; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 18576; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 18576; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 43521; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 50885425806674 (cs), LOT # 65296; CATALOG # SAN68PEVUL, GTIN 885425806679 (ea) 508
- 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… (this page)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…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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