Medline Industries, LP
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog Number: DYNJT10197; 2) CRANIOTOMY #IMF 56646-LF, Catalog Number: DYNJVB91001; 3) CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348O; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348P; 5) LAMINECTOMY PACK-LF, Catalog Number: DYNJ04342M; 6) LAMINECTOMY PACK-LF, Catalog Number: DYNJ43218G; 7) CRANIOTOMY PACK, Catalog Number: DYNJ46024F; 8) LAMINECTOMY PACK-LF, Catalog Number: DYNJ46070C; 9) CRANI PACK, Catalog Number: DYNJ46672B; 10) SPINE TRAY II, Catalog Number: DYNJ52961I; 11) SPINE PACK, Catalog Number: DYNJ53518C; 12) SPINE PACK, Catalog Number: DYNJ54479C; 13) CRANI ADJUNCT PACK, Catalog Number: DYNJ57815; 14) WC SPINE PACK-LF, Catalog Number: DYNJ57971C; 15) PEDI CRANI MAJOR, Catalog Number: DYNJ59338C; 16) LAMINECTOMY PACK-LF, Catalog Number: DYNJ66742C; 17) SPINAL PACK-LF, Catalog Number: DYNJ67543B; 18) LAMINECTOMY PACK, Catalog Number: DYNJ69214A; 19) EPCH LAMINECTOMY I PACK, Catalog Number: DYNJ83098; 20) SPINE, Catalog Number: DYNJ900269I; 21) PACK,CRANIOTOMY, Catalog Number: DYNJ906893C; 22) PACK,CRANIOTOMY, Catalog Number: DYNJ906893D; 23) PACK,CRANIOTOMY, Catalog Number: DYNJ906893F; 24) UNIVERSITY CRANIOTOMY, Catalog Number: DYNJ907192B; 25) UNIVERSITY CRANIOTOMY, Catalog Number: DYNJ907192C; 26) DR MOSHEL CRANI, Catalog Number: DYNJ907920C; 27) SPINE-LF, Catalog Number: DYNJ910956; 28) TOURO OR LAMINECTOMY PACK, Catalog Number: DYNJ912687
1) DYNJT10197, UDI-DI: 10198459778865(each), 40198459778866(case), Lot Number: 26GBA998; 2) DYNJVB91001, UDI-DI: 10193489801170(each), 40193489801171(case), Lot Number: 23HLA649; 3) DYNJVB91001, UDI-DI: 10193489801170(each), 40193489801171(case), Lot Number: 23GLA935; 4) DYNJVB91001, UDI-DI: 10193489801170(each), 40193489801171(case), Lot Number: 23GLA081; 5) DYNJVB91001, UDI-DI: 10193489801170(each), 40193489801171(case), Lot Number: 23CLA457; 6) DYNJVB91001, UDI-DI: 10193489801170(each), 40193489801171(case), Lot Number: 23BLA516; 7) DYNJ0369348O, UDI-DI: 10195327025892(each), 40195327025893(case), Lot Number: 22IBO169; 8) DYNJ0369348O, UDI-DI: 10195327025892(each), 40195327025893(case), Lot Number: 22GBD964; 9) DYNJ0369348O, UDI-DI: 10195327025892(each), 40195327025893(case), Lot Number: 22DBU156; 10) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24KBH955; 11) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24JBB595; 12) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24GMF624; 13) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24CMJ263; 14) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24BMK244; 15) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 24AMF230; 16) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23JBJ151; 17) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23FBG216; 18) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23EBC638; 19) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23CBI768; 20) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23ABM980; 21) DYNJ0369348P, UDI-DI: 10195327295417(each), 40195327295418(case), Lot Number: 23ABI593; 22) DYNJ04342M, UDI-DI: 10193489914672(each), 40193489914673(case), Lot Number: 23HMB096; 23) DYNJ43218G, UDI-DI: 10195327421977(each), 40195327421978(case), Lot Number: 23HMC253; 24) DYNJ46024F, UDI-DI: 10195327237011(each), 40195327237012(case), Lot Number: 23HBJ773; 25) DYNJ46070C, UDI-DI: 10193489853230(each), 40193489853231(case), Lot Number: 23HMC669; 26) DYNJ46672B, UDI-DI: 10889942278909(each), 40889942278900(case), Lot Number: 23HMA338; 27) DYNJ52961I, UDI-DI: 10195327346119(each), 40195327346110(case), Lot Number: 23HBD216; 28) DYNJ53518C, UDI-DI: 10195327054502(each), 40195327054503(case), Lot Number: 23CBG270; 29) DYNJ53518C, UDI-DI: 10195327054502(each), 40195327054503(case), Lot Number: 23BBB578; 30) DYNJ53518C, UDI-DI: 10195327054502(each), 40195327054503(case), Lot Number: 22LBP140; 31) DYNJ54479C, UDI-DI: 10193489460254(each), 40193489460255(case), Lot Number: 23HBA720; 32) DYNJ57815, UDI-DI: 10889942779437(each), 40889942779438(case), Lot Number: 23HBP930; 33) DYNJ57971C, UDI-DI: 10195327225209(each), 40195327225200(case), Lot Number: 23GBT243; 34) DYNJ59338C, UDI-DI: 10195327021238(each), 40195327021239(case), Lot Number: 23HLA933; 35) DYNJ66742C, UDI-DI: 10195327343156(each), 40195327343157(case), Lot Number: 23GBS430; 36) DYNJ67543B, UDI-DI: 10195327471606(each), 40195327471607(case), Lot Number: 23HBG744; 37) DYNJ69214A, UDI-DI: 10195327184056(each), 40195327184057(case), Lot Number: 23GBR467; 38) DYNJ83098, UDI-DI: 10195327231316(each), 40195327231317(case), Lot Number: 23HMA427; 39) DYNJ900269I, UDI-DI: 10198459569524(each), 40198459569525(case), Lot Number: 26CMI592; 40) DYNJ906893C, UDI-DI: 10193489974713(each), 40193489974714(case), Lot Number: 22IBC626; 41) DYNJ906893C, UDI-DI: 10193489974713(each), 40193489974714(case), Lot Number: 22HBS240; 42) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24JMH504; 43) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24JMD199; 44) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24IMG055; 45) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24GMJ361; 46) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24EMD234; 47) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24DMG428; 48) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24BMI349; 49) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 24AMG705; 50) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23LMF389; 51) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23JMK268; 52) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23JMB370; 53) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23IMC078; 54) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23HMH387; 55) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23GMD961; 56) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23DME252; 57) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23DMB260; 58) DYNJ906893D, UDI-DI: 10195327303372(each), 40195327303373(case), Lot Number: 23CMG273; 59) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 26GMG394; 60) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 26FMD545; 61) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 26DMD616; 62) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 26DMA441; 63) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 26DMA421; 64) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25KMJ807; 65) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25KMB625; 66) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25HMI954; 67) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25FMC018; 68) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25EMF909; 69) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25CMF056; 70) DYNJ906893F, UDI-DI: 10198459168734(each), 40198459168735(case), Lot Number: 25AMF815; 71) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 25GBW221; 72) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 25GBD210; 73) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 25EBM992; 74) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 25DBN524; 75) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 25BBQ529; 76) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24LBP184; 77) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24KBH441; 78) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24JBD802; 79) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24IBK611; 80) DYNJ907192B, UDI-DI: 24GBX565(each), 10193489946581(case), Lot Number: 40193489946582; 81) DYNJ907192B, UDI-DI: 24FBB829(each), 10193489946581(case), Lot Number: 40193489946582; 82) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24DBV145; 83) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24CBM496; 84) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 24ABP283; 85) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23KBN917; 86) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23JBR304; 87) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23IBU169; 88) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23IBH841; 89) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23FBH149; 90) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23EBL017; 91) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23CBP523; 92) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23BBF825; 93) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 23BBF826; 94) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 22JBL437; 95) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 22IBA578; 96) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 22IBA287; 97) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 22GBI511; 98) DYNJ907192B, UDI-DI: 10193489946581(each), 40193489946582(case), Lot Number: 22GBH553; 99) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 26FBR970; 100) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 26EBL570; 101) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 26DBL401; 102) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 26CBD787; 103) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 25LBB786; 104) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 25JBQ411; 105) DYNJ907192C, UDI-DI: 10198459479588(each), 40198459479589(case), Lot Number: 25JBH229; 106) DYNJ907920C, UDI-DI: 10198459124839(each), 40198459124830(case), Lot Number: 26DBQ234; 107) DYNJ910956, UDI-DI: 10198459210884(each), 40198459210885(case), Lot Number: 25GMA962; 108) DYNJ910956, UDI-DI: 10198459210884(each), 40198459210885(case), Lot Number: 25CMJ170; 109) DYNJ912687, UDI-DI: 10198459758485(each), 40198459758486(case), Lot Number: 26EBH822
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →