Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE
Cardinal Health 200, LLC
The hazard
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog Number: PE33HNCR2; 9) KIT, HEAD AND NECK , Catalog Number: PE33HNCR3; 10) KIT, HEAD AND NECK , Catalog Number: PE33HNCR4; 11) KIT, HEAD AND NECK , Catalog Number: PE33HNCRA; 12) KIT, HEAD AND NECK , Catalog Number: PE33HNCRB; 13) KIT, NASAL , Catalog Number: PE35NSB23; 14) KIT, NASAL , Catalog Number: PE35NSBLG; 15) KIT, EENT , Catalog Number: PE44EMKW8;
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model 1) 24-0726AModel UDI-DI: 10195594855130(each)Model 50195594855138(case)Model Lot Number: 4730Model 2) 24-0726AModel 3) 24-0726AModel 4) 24-0726AModel Lot Number: 3747Model 5) PE13SPAJAModel UDI-DI: 10195594732189(each)Model 50195594732187(case)Model Lot Number: 4366Model 6) PE13SPAJAModel Lot Number: 2390Model 7) PE13SPAJAUPC 10195594855130UPC 50195594855138UPC 10195594732189UPC 50195594732187UPC 10197106290910UPC 50197106290918Would you have heard about this one?
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