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;

Official notice

Original summary

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 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. 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,