Medline Industries, LP recalls Medline Convenience Kits: 1) ANTERIOR SPINE PACK, Catalog N

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: 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