Medline Industries, LP

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Medline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS, Model Number: CDS983523G; 3) C-SECTION, Model Number: CDSCCR611O; 4) C-SECTION, Model Number: CDSCCR611P; 5) LUD C-SECTION-LF, Model Number: DYNJ0101616I; 6) C-SECTION TRAY, Model Number: DYNJ15494G; 7) C-SECTION TRAY-LF, Model Number: DYNJ19529P; 8) C-SECTION TRAY-LF, Model Number: DYNJ19529Q; 9) C-SECTION TRAY-LF, Model Number: DYNJ19529R; 10) C-SECTION TRAY-LF, Model Number: DYNJ19529S; 11) C-SECTION PACK-LF, Model Number: DYNJ21550Q; 12) C-SECTION PACK, Model Number: DYNJ23544F; 13) C-SECTION PACK, Model Number: DYNJ32632F; 14) C-SECTION PACK QVH-LF, Model Number: DYNJ35100I; 15) C-SECTION PACK-LF, Model Number: DYNJ38801F; 16) SCRIPPS SW C-SECTION PACK-LF, Model Number: DYNJ40129C; 17) C-SECTION, Model Number: DYNJ41444F; 18) C-SECTION PACK, Model Number: DYNJ49224I; 19) C SECTION PACK-LF, Model Number: DYNJ52387I; 20) C-SECTION PACK, Model Number: DYNJ56523C; 21) C-SECTION PACK, Model Number: DYNJ59387L; 22) C-SECTION PACK, Model Number: DYNJ64549B; 23) C SECTION PACK, Model Number: DYNJ67347A; 24) C SECTION PACK, Model Number: DYNJ69778A; 25) B-C SECTION BAYSTATE, Model Number: DYNJ900602I; 26) B-C SECTION BAYSTATE, Model Number: DYNJ900602K; 27) PAD C-SECTION, Model Number: DYNJ902134C; 28) RICH C-SECTION, Model Number: DYNJ902182J; 29) C-SECTION PACK, Model Number: DYNJ904329D; 30) C-SECTION, Model Number: DYNJ904697F; 31) KIT C SECTION, Model Number: DYNJ906966G; 32) C SECTION, Model Number: DYNJ907999A; 33) C-SECTION, Model Number: DYNJ909058; 34) C-SECTION PACK, Model Number: DYNJ909507; 35) C SECTION TRAY, Model Number: DYNJT3407; 36) TR-C SECTION PACK-LF, Model Number: PHS583549002B

1) CDS820080N, UDI-DI: 10195327278014(each), 40195327278015(case), Lot Number: 23IMB818; 2) CDS983523G, UDI-DI: 10195327283681(each), 40195327283682(case), Lot Number: 23IBS984; 3) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21WBA953; 4) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21LBC555; 5) CDSCCR611O, UDI-DI: 10193489367904(each), 40193489367905(case), Lot Number: 21CBN328; 6) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22IBG757; 7) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU298; 8) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU297; 9) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22FBU296; 10) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22EBA155; 11) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBT090; 12) CDSCCR611P, UDI-DI: 10195327065850(each), 40195327065851(case), Lot Number: 22BBH774; 13) DYNJ0101616I, UDI-DI: 10193489248814(each), 40193489248815(case), Lot Number: 21ADA105; 14) DYNJ15494G, UDI-DI: 10193489961195(each), 40193489961196(case), Lot Number: 22LBS122; 15) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24GMF054; 16) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24FMB372; 17) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24EMB123; 18) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 24AMD085; 19) DYNJ19529P, UDI-DI: 10195327529338(each), 40195327529339(case), Lot Number: 23LME909; 20) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 25BMB041; 21) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24LMH886; 22) DYNJ19529Q, UDI-DI: 10198459109362(each), 40198459109363(case), Lot Number: 24KMD458; 23) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25IMA090; 24) DYNJ19529R, UDI-DI: 10198459311031(each), 40198459311032(case), Lot Number: 25FMI427; 25) DYNJ19529S, UDI-DI: 10198459566257(each), 40198459566258(case), Lot Number: 25KMA045; 26) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBL994; 27) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21DBJ153; 28) DYNJ21550Q, UDI-DI: 10193489830910(each), 40193489830911(case), Lot Number: 21BBM422; 29) DYNJ23544F, UDI-DI: 10889942533053(each), 40889942533054(case), Lot Number: 23IMA860; 30) DYNJ32632F, UDI-DI: 10193489888966(each), 40193489888967(case), Lot Number: 22HMC526; 31) DYNJ35100I, UDI-DI: 10195327097608(each), 40195327097609(case), Lot Number: 23IME105; 32) DYNJ38801F, UDI-DI: 10195327113117(each), 40195327113118(case), Lot Number: 23IBK585; 33) DYNJ40129C, UDI-DI: 10193489441772(each), 40193489441773(case), Lot Number: 23AMJ303; 34) DYNJ41444F, UDI-DI: 10193489740974(each), 40193489740975(case), Lot Number: 22JMB590; 35) DYNJ49224I, UDI-DI: 10193489371352(each), 40193489371353(case), Lot Number: 21DDA358; 36) DYNJ52387I, UDI-DI: 10193489248272(each), 40193489248273(case), Lot Number: 21ADA540; 37) DYNJ56523C, UDI-DI: 10193489430264(each), 40193489430265(case), Lot Number: 21ABS513; 38) DYNJ59387L, UDI-DI: 10195327159856(each), 40195327159857(case), Lot Number: 23CBK420; 39) DYNJ64549B, UDI-DI: 10193489940725(each), 40193489940726(case), Lot Number: 23ABL355; 40) DYNJ67347A, UDI-DI: 10195327046156(each), 40195327046157(case), Lot Number: 22JMF954; 41) DYNJ69778A, UDI-DI: 10195327334420(each), 40195327334421(case), Lot Number: 23CBU899; 42) DYNJ900602I, UDI-DI: 10193489487121(each), 40193489487122(case), Lot Number: 20LDB302; 43) DYNJ900602K, UDI-DI: 10193489937190(each), 40193489937191(case), Lot Number: 25JDA979; 44) DYNJ902134C, UDI-DI: 10193489452280(each), 40193489452281(case), Lot Number: 21DBP451; 45) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 23ABM580; 46) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22OBJ456; 47) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22JBO865; 48) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22IBI254; 49) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22HBF417; 50) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22GBH232; 51) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22EBG610; 52) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22DBN664; 53) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 22ABY311; 54) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21JBX738; 55) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21JBJ172; 56) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21IBL808; 57) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21GBB842; 58) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21CBS046; 59) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21CBQ743; 60) DYNJ902182J, UDI-DI: 10193489452914(each), 40193489452915(case), Lot Number: 21BBF750; 61) DYNJ904329D, UDI-DI: 10198459221071(each), 40198459221072(case), Lot Number: 25EBJ650; 62) DYNJ904697F, UDI-DI: 10195327169275(each), 40195327169276(case), Lot Number: 22FDA703; 63) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24IBS185; 64) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24IBF270; 65) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24GBV882; 66) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24GBR695; 67) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24DBN053; 68) DYNJ906966G, UDI-DI: 10195327557959(each), 40195327557950(case), Lot Number: 24BBV274; 69) DYNJ907999A, UDI-DI: 10193489996814(each), 40193489996815(case), Lot Number: 22CMH174; 70) DYNJ907999A, UDI-DI: 10193489996814(each), 40193489996815(case), Lot Number: 21LMB616; 71) DYNJ907999A, UDI-DI: 10193489996814(each), 40193489996815(case), Lot Number: 21JMC590; 72) DYNJ909058, UDI-DI: 10195327259327(each), 40195327259328(case), Lot Number: 23EBP308; 73) DYNJ909507, UDI-DI: 10195327387075(each), 40195327387076(case), Lot Number: 23GME519; 74) DYNJT3407, UDI-DI: 10198459324970(each), 40198459324971(case), Lot Number: 25EBK673; 75) PHS583549002B, UDI-DI: 10193489643558(each), 40193489643559(case), Lot Number: 21ADA554