MEDLINE Medical Procedure Kits labeled as CH OPEN HEART, ADULT CARDIAC KIT, AHT CVOR CABG, APH EMERGENCY OPEN HEART PACK, Etc. (see recall documents for a full list of products)
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
Issued by
FDA
Distribution: Nationwide (United States)
Lot/Code Info: Medline Kit Number/SKU CDS983773G: UDI/DI 10193489344240 (each), 40193489344241 (case), Lot Number 21ABD933; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22IBJ338; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL456; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22EBL231; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22BBW955; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 22ABC123; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBM442; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21IBI539; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21FBT730; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21EBA066; Medline Kit Number/SKU CDS983773I: UDI/DI 10193489847123 (each), 40193489847124 (case), Lot Number 21CBW872; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23HBV936; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23HBL135; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23HBH924; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23GBT133; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23GBD523; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 23ABM749; Medline Kit Number/SKU CDS983773J: UDI/DI 10195327233617 (each), 40195327233618 (case), Lot Number 22JBH775; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24EDB118; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24DDC044; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24BDB774; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADB944; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADA835; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADA564; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 23KDB417; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 21KDB767; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 21IDC416; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24BDB595; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 24ADB653; Medline Kit Number/SKU DYNJ39755A: UDI/DI 10193489670233 (each), 40193489670234 (case), Lot Number 22DDA063; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 23JBQ990; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 23GBS121; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22HBB007; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22FBC016; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22BBE079; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 22ABJ835; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 21IBG139; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 21BBA612; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 21ABU423; Medline Kit Number/SKU DYNJ46712: UDI/DI 10888277252998 (each), 40888277252999 (case), Lot Number 21ABP812; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21LMG772; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21LMF805; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21KMD456; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21KMC752; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21KMA494; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21IME819; Medline Kit Number/SKU DYNJ905177B: UDI/DI 10193489940497 (each), 40193489940498 (case), Lot Number 21IMC689; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 26DBE056; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 26ABF332; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 25LBK229; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 25JBO789; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 25JBH875; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 25IBM650; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 25IBF700; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 25HBD626; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 25ABV590; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 25ABO560; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 25ABG777; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 24LBN438; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 24LBD202; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 24DBR114; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 24DBH241; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 24CBO186; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 23EBW651; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 23ABQ782; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 23ABK494; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 23ABK506; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 22JBI812; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 22JBI813; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 22IBJ400; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 22IBE267; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 22GBT554; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 22GBR220; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 21KBI416; Medline Kit Number/SKU DYNJ907654: UDI/DI 10193489839012 (each), 40193489839013 (case), Lot Number 21GMD431; Medline Kit Number/SKU DYNJ58936A: UDI/DI 10193489852219 (each), 40193489852210 (case), Lot Number 21KDA682; Medline Kit Number/SKU CDS983346K: UDI/DI 10198459701993 (each), 40198459701994 (case), Lot Number 26DBH084; Medline Kit Number/SKU DYNJ904018D: UDI/DI 10193489470987 (each), 40193489470988 (case), Lot Number 23ABL016; Medline Kit Number/SKU DYNJ904018D: UDI/DI 10193489470987 (each), 40193489470988 (case), Lot Number 22LBF503; Medline Kit Number/SKU DYNJ904018D: UDI/DI 10193489470987 (each), 40193489470988 (case), Lot Number 22IBI782; Medline Kit Number/SKU DYNJ904018D: UDI/DI 10193489470987 (each), 40193489470988 (case), Lot Number 22HBX951; Medline Kit Number/SKU DYNJ904018D: UDI/DI 10193489470987 (each), 40193489470988 (case), Lot Number 22HBX953; Medline Kit Number/SKU DYNJ904018D: UDI/DI 10193489470987 (each), 40193489470988 (case), Lot Number 22HBX958; Medline Kit Number/SKU DYNJ904018D: UDI/DI 10193489470987 (each), 40193489470988 (case), Lot Number 22FBQ297; Medline Kit Number/SKU DYNJ904018D: UDI/DI 10193489470987 (each), 40193489470988 (case), Lot Number 22DBQ756; Medline Kit Number/SKU DYNJ904018D: UDI/DI 10193489470987 (each), 40193489470988 (case), Lot Number 22DBI485; Medline Kit Number/SKU DYNJ904018D: UDI/DI 10193489470987 (each), 40193489470988 (case), Lot Number 22DBJ428; Medline Kit Number/SKU DYNJ904018D: UDI/DI 10193489470987 (each), 40193489470988 (case), Lot Number 22DBD936; Medline Kit Number/SKU DYNJ904018D: UDI/DI 10193489470987 (each), 40193489470988 (case), Lot Number 21KBW974; Medline Kit Number/SKU DYNJ904018D: UDI/DI 10193489470987 (each), 40193489470988 (case), Lot Number 21JBZ346; Medline Kit Number/SKU DYNJ89735: UDI/DI 10198459289507 (each), 40198459289508 (case), Lot Number 25LBG122; Medline Kit Number/SKU DYNJ89735: UDI/DI 10198459289507 (each), 40198459289508 (case), Lot Number 25FBH481; Medline Kit Number/SKU DYNJ89735: UDI/DI 10198459289507 (each), 40198459289508 (case), Lot Number 25EBQ316; Medline Kit Number/SKU DYNJ89735: UDI/DI 10198459289507 (each), 40198459289508 (case), Lot Number 25DBQ231; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 26DME626; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 26AMJ899; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 26AMG841; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 25LME920; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 25LMB681; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 25JME847; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 25GMG955; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 25EMD791; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 25DMB828; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 25BMD432; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 24JMC886; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 24HMG290; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 24HMF593; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 24EMJ179; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 24DMD008; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 24CMB699; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 24BMD685; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 24AMD954; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 23JMI748; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 23JMB438; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 23IMD775; Medline Kit Number/SKU CDS982277N: UDI/DI 10195327472818 (each), 40195327472819 (case), Lot Number 23IMA468; Medline Kit Number/SKU DYNJ9149605K: UDI/DI 10193489290714 (each), 40193489290715 (case), Lot Number 22IBN892; Medline Kit Number/SKU DYNJ9149605K: UDI/DI 10193489290714 (each), 40193489290715 (case), Lot Number 22EBG048; Medline Kit Number/SKU DYNJ9149605K: UDI/DI 10193489290714 (each), 40193489290715 (case), Lot Number 22OBA465; Medline Kit Number/SKU DYNJ9149605K: UDI/DI 10193489290714 (each), 40193489290715 (case), Lot Number 22ABZ357; Medline Kit Number/SKU DYNJ9149605K: UDI/DI 10193489290714 (each), 40193489290715 (case), Lot Number 22ABC909; Medline Kit Number/SKU DYNJ9149605K: UDI/DI 10193489290714 (each), 40193489290715 (case), Lot Number 21JBA003; Medline Kit Number/SKU DYNJ9149605K: UDI/DI 10193489290714 (each), 40193489290715 (case), Lot Number 21JBA002; Medline Kit Number/SKU DYNJ9149605L: UDI/DI 10195327235598 (each), 40195327235599 (case), Lot Number 22LBJ936; Medline Kit Number/SKU DYNJ9149605N: UDI/DI 10195327387136 (each), 40195327387137 (case), Lot Number 23FBO505; Medline Kit Number/SKU DYNJ9149605N: UDI/DI 10195327387136 (each), 40195327387137 (case), Lot Number 23EBH576; Medline Kit Number/SKU DYNJ9149605N: UDI/DI 10195327387136 (each), 40195327387137 (case), Lot Number 23EBD511; Medline Kit Number/SKU DYNJ9149605O: UDI/DI 10195327487102 (each), 40195327487103 (case), Lot Number 23KBG171; Medline Kit Number/SKU DYNJ9149605O: UDI/DI 10195327487102 (each), 40195327487103 (case), Lot Number 23IBD866; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 25BBP832; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 25BBC798; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 24LBI169; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 24KBK717; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 24JBR860; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 24FBE336; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 24FBE658; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 24CBV465; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 24CBM098; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 24ABG158; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 23LBE599; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 23IBI963; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 23IBH624; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 23FBC058; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 23DBL999; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 23BBI412; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 23BBI422; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 23BBB459; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 22KBU487; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 22KBU530; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 22IBV962; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 22HBA445; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 22FBU311; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 22FBU774; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 22EBF940; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 22NBF890; Medline Kit Number/SKU CDS982411N: UDI/DI 10195327031589 (each), 40195327031580 (case), Lot Number 21LBM326; Medline Kit Number/SKU CDS983147I: UDI/DI 10195327075514 (each), 40195327075515 (case), Lot Number 23EBH362; Medline Kit Number/SKU CDS983147I: UDI/DI 10195327075514 (each), 40195327075515 (case), Lot Number 23DBN635; Medline Kit Number/SKU CDS983147I: UDI/DI 10195327075514 (each), 40195327075515 (case), Lot Number 23CBW418; Medline Kit Number/SKU CDS983147I: UDI/DI 10195327075514 (each), 40195327075515 (case), Lot Number 23ABN787; Medline Kit Number/SKU CDS983147I: UDI/DI 10195327075514 (each), 40195327075515 (case), Lot Number 22JBK709; Medline Kit Number/SKU CDS983147I: UDI/DI 10195327075514 (each), 40195327075515 (case), Lot Number 22IBH961; Medline Kit Number/SKU CDS983147I: UDI/DI 10195327075514 (each), 40195327075515 (case), Lot Number 22HBD661; Medline Kit Number/SKU CDS983147I: UDI/DI 10195327075514 (each), 40195327075515 (case), Lot Number 22FBX070; Medline Kit Number/SKU CDS983147J: UDI/DI 10195327399887 (each), 40195327399888 (case), Lot Number 24CBO135; Medline Kit Number/SKU CDS983147K: UDI/DI 10195327658489 (each), 40195327658480 (case), Lot Number 24FBK670; Medline Kit Number/SKU CDS983147K: UDI/DI 10195327658489 (each), 40195327658480 (case), Lot Number 24EBL383; Medline Kit Number/SKU CDS983147K: UDI/DI 10195327658489 (each), 40195327658480 (case), Lot Number 24EBI931; Medline Kit Number/SKU CDS983147L: UDI/DI 10198459023880 (each), 40198459023881 (case), Lot Number 24FBI448; Medline Kit Number/SKU CDS983147L: UDI/DI 10198459023880 (each), 40198459023881 (case), Lot Number 24FBG820; Medline Kit Number/SKU DYNJ909360: UDI/DI 10195327319120 (each), 40195327319121 (case), Lot Number 24DME042; Medline Kit Number/SKU DYNJ909360: UDI/DI 10195327319120 (each), 40195327319121 (case), Lot Number 24BMA817; Medline Kit Number/SKU DYNJ909360: UDI/DI 10195327319120 (each), 40195327319121 (case), Lot Number 23FMC735; Medline Kit Number/SKU DYNJ909360: UDI/DI 10195327319120 (each), 40195327319121 (case), Lot Number 23EME762; Medline Kit Number/SKU DYNJ67331A: UDI/DI 10193489870893 (each), 40193489870894 (case), Lot Number 21HBM814; Medline Kit Number/SKU DYNJ67331A: UDI/DI 10193489870893 (each), 40193489870894 (case), Lot Number 21GBL132; Medline Kit Number/SKU DYNJ67331A: UDI/DI 10193489870893 (each), 40193489870894 (case), Lot Number 21FBL463; Medline Kit Number/SKU DYNJ65222: UDI/DI 10193489254136 (each), 40193489254137 (case), Lot Number 22ALA391; Medline Kit Number/SKU DYNJ65222: UDI/DI 10193489254136 (each), 40193489254137 (case), Lot Number 22ALA039; Medline Kit Number/SKU DYNJ65222: UDI/DI 10193489254136 (each), 40193489254137 (case), Lot Number 21KLA327; Medline Kit Number/SKU CDS981533F: UDI/DI 10889942643691 (each), 40889942643692 (case), Lot Number 22OBB041; Medline Kit Number/SKU CDS981533F: UDI/DI 10889942643691 (each), 40889942643692 (case), Lot Number 21JBS090; Medline Kit Number/SKU CDS981533F: UDI/DI 10889942643691 (each), 40889942643692 (case), Lot Number 21IBC821; Medline Kit Number/SKU CDS981533F: UDI/DI 10889942643691 (each), 40889942643692 (case), Lot Number 21GBI109; Medline Kit Number/SKU CDS981533F: UDI/DI 10889942643691 (each), 40889942643692 (case), Lot Number 21DBK232; Medline Kit Number/SKU CDS981533F: UDI/DI 10889942643691 (each), 40889942643692 (case), Lot Number 21DBI909; Medline Kit Number/SKU CDS981533G: UDI/DI 10195327171421 (each), 40195327171422 (case), Lot Number 23BBS065; Medline Kit Number/SKU CDS981533G: UDI/DI 10195327171421 (each), 40195327171422 (case), Lot Number 23BBH044; Medline Kit Number/SKU CDS981533G: UDI/DI 10195327171421 (each), 40195327171422 (case), Lot Number 23BBH020; Medline Kit Number/SKU CDS981533G: UDI/DI 10195327171421 (each), 40195327171422 (case), Lot Number 22JBW502; Medline Kit Number/SKU CDS981533G: UDI/DI 10195327171421 (each), 40195327171422 (case), Lot Number 22JBH531; Medline Kit Number/SKU CDS981533G: UDI/DI 10195327171421 (each), 40195327171422 (case), Lot Number 22IBM172; Medline Kit Number/SKU CDS981533G: UDI/DI 10195327171421 (each), 40195327171422 (case), Lot Number 22HBS264; Medline Kit Number/SKU CDS981533G: UDI/DI 10195327171421 (each), 40195327171422 (case), Lot Number 22HBA264; Medline Kit Number/SKU CDS981533I: UDI/DI 10195327360535 (each), 40195327360536 (case), Lot Number 25CBD672; Medline Kit Number/SKU CDS981533I: UDI/DI 10195327360535 (each), 40195327360536 (case), Lot Number 25BBQ409; Medline Kit Number/SKU CDS981533I: UDI/DI 10195327360535 (each), 40195327360536 (case), Lot Number 24KBN332; Medline Kit Number/SKU CDS981533I: UDI/DI 10195327360535 (each), 40195327360536 (case), Lot Number 24KBJ289; Medline Kit Number/SKU CDS981533I: UDI/DI 10195327360535 (each), 40195327360536 (case), Lot Number 24IBB234; Medline Kit Number/SKU CDS981533I: UDI/DI 10195327360535 (each), 40195327360536 (case), Lot Number 24HBU967; Medline Kit Number/SKU CDS981533I: UDI/DI 10195327360535 (each), 40195327360536 (case), Lot Number 24HBI088; Medline Kit Number/SKU CDS981533I: UDI/DI 10195327360535 (each), 40195327360536 (case), Lot Number 24HBB100; Medline Kit Number/SKU CDS981533I: UDI/DI 10195327360535 (each), 40195327360536 (case), Lot Number 24GBF498; Medline Kit Number/SKU CDS981533I: UDI/DI 10195327360535 (each), 40195327360536 (case), Lot Number 24FBG720; Medline Kit Number/SKU CDS981533I: UDI/DI 10195327360535 (each), 40195327360536 (case), Lot Number 24FBA016; Medline Kit Number/SKU CDS981533I: UDI/DI 10195327360535 (each), 40195327360536 (case), Lot Number 24DBA986; Medline Kit Number/SKU CDS981533I: UDI/DI 10195327360535 (each), 40195327360536 (case), Lot Number 24CBL314; Medline Kit Number/SKU CDS981533I: UDI/DI 10195327360535 (each), 40195327360536 (case), Lot Number 23JBQ890; Medline Kit Number/SKU CDS981533I: UDI/DI 10195327360535 (each), 40195327360536 (case), Lot Number 23JBO037; Medline Kit Number/SKU CDS981533J: UDI/DI 10198459275821 (each), 40198459275822 (case), Lot Number 26DBF999; Medline Kit Number/SKU CDS981533J: UDI/DI 10198459275821 (each), 40198459275822 (case), Lot Number 26CBM095; Medline Kit Number/SKU CDS981533J: UDI/DI 10198459275821 (each), 40198459275822 (case), Lot Number 26CBM114; Medline Kit Number/SKU CDS981533J: UDI/DI 10198459275821 (each), 40198459275822 (case), Lot Number 25LBH228; Medline Kit Number/SKU CDS981533J: UDI/DI 10198459275821 (each), 40198459275822 (case), Lot Number 25KBT472; Medline Kit Number/SKU CDS981533J: UDI/DI 10198459275821 (each), 40198459275822 (case), Lot Number 25IBD499; Medline Kit Number/SKU CDS981533J: UDI/DI 10198459275821 (each), 40198459275822 (case), Lot Number 25GBL075; Medline Kit Number/SKU CDS981533J: UDI/DI 10198459275821 (each), 40198459275822 (case), Lot Number 25GBI110; Medline Kit Number/SKU CDS981533J: UDI/DI 10198459275821 (each), 40198459275822 (case), Lot Number 25EBS812; Medline Kit Number/SKU CDS981533J: UDI/DI 10198459275821 (each), 40198459275822 (case), Lot Number 25EBJ712; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 24ABH054; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 23KBV922; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 23HBG728; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 23GBH480; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 23FBD644; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 23EBS593; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 23EBB121; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 23DBN079; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 23ABS504; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 22LBK278; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 22LBB753; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 22GME499; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 22EME013; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 22DME759; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 22AMD194; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 21LME235; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 21GMD162; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 21FMC283; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 21EME428; Medline Kit Number/SKU DYNJ53739A: UDI/DI 10193489438888 (each), 40193489438889 (case), Lot Number 21DMA150; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 24DLA357; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 24CLA265; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 24ALA680; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 23LLA182; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 23KLA328; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 23JLA878; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 23ILA555; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 23ILA384; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 23ILA088; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 23GLA455; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 23FLA494; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 23GLA155; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 23CLB066; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 23CLA766; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 23BLA562; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 23BLA257; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 22LLA788; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 22KLB041; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 22JBA759; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 22IBH040; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 22FBV093; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 22EBN201; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 22BBW160; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 22MBA654; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 21KBA047; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 21HBV103; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 21FBF408; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 21DBU723; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 21DBK103; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 21CBI758; Medline Kit Number/SKU DYNJ906878A: UDI/DI 10193489391305 (each), 40193489391306 (case), Lot Number 23DLB056; Medline Kit Number/SKU DYNJ906878B: UDI/DI 10198459029776 (each), 40198459029777 (case), Lot Number 24GLA464; Medline Kit Number/SKU DYNJ909833: UDI/DI 10195327498962 (each), 40195327498963 (case), Lot Number 24EMH863; Medline Kit Number/SKU DYNJ909833: UDI/DI 10195327498962 (each), 40195327498963 (case), Lot Number 24AMF107; Medline Kit Number/SKU DYNJ909833: UDI/DI 10195327498962 (each), 40195327498963 (case), Lot Number 23JMD321; Medline Kit Number/SKU DYNJ9372030F: UDI/DI 10193489668070 (each), 40193489668071 (case), Lot Number 21IBD619; Medline Kit Number/SKU DYNJ9773729J: UDI/DI 10193489863802 (each), 40193489863803 (case), Lot Number 21FBN582; Medline Kit Number/SKU DYNJ9773729L: UDI/DI 10198459052453 (each), 40198459052454 (case), Lot Number 25CBO356; Medline Kit Number/SKU DYNJ9773729L: UDI/DI 10198459052453 (each), 40198459052454 (case), Lot Number 25CBF589; Medline Kit Number/SKU DYNJ9773729L: UDI/DI 10198459052453 (each), 40198459052454 (case), Lot Number 25BBH968; Medline Kit Number/SKU DYNJ9773729L: UDI/DI 10198459052453 (each), 40198459052454 (case), Lot Number 25ABJ366; Medline Kit Number/SKU DYNJ9773729L: UDI/DI 10198459052453 (each), 40198459052454 (case), Lot Number 24LBA335; Medline Kit Number/SKU DYNJ9773729L: UDI/DI 10198459052453 (each), 40198459052454 (case), Lot Number 24JBT373; Medline Kit Number/SKU DYNJ9773729L: UDI/DI 10198459052453 (each), 40198459052454 (case), Lot Number 24HBM994; Medline Kit Number/SKU DYNJ9773729M: UDI/DI 10198459319396 (each), 40198459319397 (case), Lot Number 26DBM954; Medline Kit Number/SKU DYNJ9773729M: UDI/DI 10198459319396 (each), 40198459319397 (case), Lot Number 26ABX040; Medline Kit Number/SKU DYNJ9773729M: UDI/DI 10198459319396 (each), 40198459319397 (case), Lot Number 26ABX013; Medline Kit Number/SKU DYNJ9773729M: UDI/DI 10198459319396 (each), 40198459319397 (case), Lot Number 25JBW154; Medline Kit Number/SKU DYNJ9773729M: UDI/DI 10198459319396 (each), 40198459319397 (case), Lot Number 25JBO569; Medline Kit Number/SKU DYNJ9773729M: UDI/DI 10198459319396 (each), 40198459319397 (case), Lot Number 25IBB600; Medline Kit Number/SKU DYNJ9773729M: UDI/DI 10198459319396 (each), 40198459319397 (case), Lot Number 25GBX068; Medline Kit Number/SKU DYNJ9773729M: UDI/DI 10198459319396 (each), 40198459319397 (case), Lot Number 25GBW955; Medline Kit Number/SKU DYNJ9773729M: UDI/DI 10198459319396 (each), 40198459319397 (case), Lot Number 25GBG260; Medline Kit Number/SKU DYNJ9773729M: UDI/DI 10198459319396 (each), 40198459319397 (case),
✅ What Should You Do?
1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.