Device product
Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc.
Z-2021-2026
Product summary
- Event
- Event 98664
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 486946 kits
- Official record key
device-enforcement:Z-2021-2026
Official wording
Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.
Code information: Medline Kit Number/SKU AM310B: UDI/DI each 10193489242126, UDI/DI case 40193489242127, Lot Number: 20XBG776; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23JBF547; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23GBK604; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23DBO915; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23DBD581; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23ABP476; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23ABD648; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22LBE888; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22HBL188; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22HBF976; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22FBN678; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22DBK641; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22BBU367; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 22ABD373; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21JBC146; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21IBA072; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21FBN768; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21FBB075; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 21EBI490; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 24CBU365; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 24BBE020; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 24ABJ712; Medline Kit Number/SKU CDS980579D: UDI/DI each 10889942133710, UDI/DI case 40889942133711, Lot Number: 23LBM852; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 26BBM084; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25LBS053; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25KBL217; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25JBA568; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25GBM602; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25FBB309; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25CBN201; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 25CBI539; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24KBJ971; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24IBV278; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24IBR437; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24HBM092; Medline Kit Number/SKU CDS980579F: UDI/DI each 10198459027734, UDI/DI case 40198459027735, Lot Number: 24FBP548; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 23GDA870; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 23FDA168; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 23ADB195; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 22EDB625; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 22CDC141; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 21JDB377; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 21IDA882; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 21HDB855; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 26BDA373; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 25HDA036; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 25EDA147; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 25DDB518; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 24KDB412; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 24JDC373; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 24FDA893; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 24EDB481; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 24BDB518; Medline Kit Number/SKU CDS981185B: UDI/DI each 10884389647141, UDI/DI case 40884389647142, Lot Number: 23LDB380; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 23CME129; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22LME628; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22KMG745; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22IMD591; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22GMH942; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22GMB473; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22EMB645; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 22AMA586; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21KMA503; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21HMF136; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21GMC528; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21FMD781; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21FMB792; Medline Kit Number/SKU CDS981692J: UDI/DI each 10193489520415, UDI/DI case 40193489520416, Lot Number: 21EME021; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 23GBM193; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 23FBN485; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 23EBP721; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 23CBX462; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 23ABM479; Medline Kit Number/SKU CDS982020R: UDI/DI each 10195327004156, UDI/DI case 40195327004157, Lot Number: 22JBW425; Medline Kit Number/SKU CDS982020S: UDI/DI each 10195327657468, UDI/DI case 40195327657469, Lot Number: 25AMI029; Medline Kit Number/SKU CDS982020S: UDI/DI each 10195327657468, UDI/DI case 40195327657469, Lot Number: 24LMH803; Medline Kit Number/SKU CDS982020S: UDI/DI each 10195327657468, UDI/DI case 40195327657469, Lot Number: 24KMG612; Medline Kit Number/SKU CDS982020S: UDI/DI each 10195327657468, UDI/DI case 40195327657469, Lot Number: 24IMI778; Medline Kit Number/SKU CDS982020T: UDI/DI each 10198459385490, UDI/DI case 40198459385491, Lot Number: 26AMG222; Medline Kit Number/SKU CDS982020T: UDI/DI each 10198459385490, UDI/DI case 40198459385491, Lot Number: 25KMF284; Medline Kit Number/SKU CDS982596L: UDI/DI each 10193489712209, UDI/DI case 40193489712200, Lot Number: 21BKA098; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23KMA344; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23HMB694; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23GMF880; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23FMI753; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23FMF062; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 23AMF870; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22LMD446; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22IMD630; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22GMC294; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22EMG730; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22CMG908; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22BME437; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 22AMB333; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 25DMD274; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 25BMB788; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 25AMH330; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24JMG325; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24GMF217; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24EMB761; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24DMA557; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24CMH849; Medline Kit Number/SKU CDS982598K: UDI/DI each 10195327069742, UDI/DI case 40195327069743, Lot Number: 24BMC117; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 23JBN252; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 23IBM139; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 23FBC217; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 23DBM203; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 23BBG600; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 22LBF819; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 22KBD129; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 22OBM290; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 22DBA891; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 22BBR017; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 21LBF094; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 25FBQ106; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 25CBU470; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 25ABI524; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 24LBC408; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 24KBM034; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 24JBN727; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 24JBC931; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 24IBL843; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 24HBV303; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 24FBT085; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 24FBG819; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 24DBD153; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 24CBO278; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 24BBP099; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 23LBT964; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 23LBG432; Medline Kit Number/SKU CDS982901F: UDI/DI each 10889942216970, UDI/DI case 40889942216971, Lot Number: 23LBE611; Medline Kit Number/SKU CDS982901G: UDI/DI each 10198459392917, UDI/DI case 40198459392918, Lot Number: 26BBT747; Medline Kit Number/SKU CDS982901G: UDI/DI each 10198459392917, UDI/DI case 40198459392918, Lot Number: 26ABF712; Medline Kit Number/SKU CDS982901G: UDI/DI each 10198459392917, UDI/DI case 40198459392918, Lot Number: 25KBE241; Medline Kit Number/SKU CDS982901G: UDI/DI each 10198459392917, UDI/DI case 40198459392918, Lot Number: 25JBN120; Medline Kit Number/SKU CDS982901G: UDI/DI each 10198459392917, UDI/DI case 40198459392918, Lot Number: 25IBD837; Medline Kit Number/SKU CDS982901G: UDI/DI each 10198459392917, UDI/DI case 40198459392918, Lot Number: 25GBV250; Medline Kit Number/SKU CDS982939Q: UDI/DI each 10193489363128, UDI/DI case 40193489363129, Lot Number: 22GBA670; Medline Kit Number/SKU CDS982939Q: UDI/DI each 10193489363128, UDI/DI case 40193489363129, Lot Number: 22EBM378; Medline Kit Number/SKU CDS982939Q: UDI/DI each 10193489363128, UDI/DI case 40193489363129, Lot Number: 22DBO694; Medline Kit Number/SKU CDS982939Q: UDI/DI each 10193489363128, UDI/DI case 40193489363129, Lot Number: 22ABZ580; Medline Kit Number/SKU CDS982939Q: UDI/DI each 10193489363128, UDI/DI case 40193489363129, Lot Number: 21LBN507; Medline Kit Number/SKU CDS982939Q: UDI/DI each 10193489363128, UDI/DI case 40193489363129, Lot Number: 21KBE082; Medline Kit Number/SKU CDS982939Q: UDI/DI each 10193489363128, UDI/DI case 40193489363129, Lot Number: 21DBA582; Medline Kit Number/SKU CDS982939Q: UDI/DI each 10193489363128, UDI/DI case 40193489363129, Lot Number: 21BBE974; Medline Kit Number/SKU CDS982939R: UDI/DI each 10195327185282, UDI/DI case 40195327185283, Lot Number: 23FBF588; Medline Kit Number/SKU CDS982939R: UDI/DI each 10195327185282, UDI/DI case 40195327185283, Lot Number: 23EBU368; Medline Kit Number/SKU CDS982939R: UDI/DI each 10195327185282, UDI/DI case 40195327185283, Lot Number: 23DBD624; Medline Kit Number/SKU CDS982939R: UDI/DI each 10195327185282, UDI/DI case 40195327185283, Lot Number: 23CBV079; Medline Kit Number/SKU CDS982939R: UDI/DI each 10195327185282, UDI/DI case 40195327185283, Lot Number: 23CBC517; Medline Kit Number/SKU CDS982939R: UDI/DI each 10195327185282, UDI/DI case 40195327185283, Lot Number: 23ABE766; Medline Kit Number/SKU CDS982939S: UDI/DI each 10195327433567, UDI/DI case 40195327433568, Lot Number: 23IBQ669; Medline Kit Number/SKU CDS982939S: UDI/DI each 10195327433567, UDI/DI case 40195327433568, Lot Number: 23GBV710; Medline Kit Number/SKU CDS982939S: UDI/DI each 10195327433567, UDI/DI case 40195327433568, Lot Number: 23LBV744; Medline Kit Number/SKU CDS982939T: UDI/DI each 10195327627393, UDI/DI case 40195327627394, Lot Number: 25BBR001; Medline Kit Number/SKU CDS982939T: UDI/DI each 10195327627393, UDI/DI case 40195327627394, Lot Number: 24JBJ453; Medline Kit Number/SKU CDS982939T: UDI/DI each 10195327627393, UDI/DI case 40195327627394, Lot Number: 24IBD749; Medline Kit Number/SKU CDS982939T: UDI/DI each 10195327627393, UDI/DI case 40195327627394, Lot Number: 24IBB628; Medline Kit Number/SKU CDS982939T: UDI/DI each 10195327627393, UDI/DI case 40195327627394, Lot Number: 24EBA105; Medline Kit Number/SKU CDS983087G: UDI/DI each 10193489237351, UDI/DI case 40193489237352, Lot Number: 23ABM169; Medline Kit Number/SKU CDS983087G: UDI/DI each 10193489237351, UDI/DI case 40193489237352, Lot Number: 22HBM964; Medline Kit Number/SKU CDS983087G: UDI/DI each 10193489237351, UDI/DI case 40193489237352, Lot Number: 22FBR222; Medline Kit Number/SKU CDS983087G: UDI/DI each 10193489237351, UDI/DI case 40193489237352, Lot Number: 22BBS399; Medline Kit Number/SKU CDS983087G: UDI/DI each 10193489237351, UDI/DI case 40193489237352, Lot Number: 22ABW442; Medline Kit Number/SKU CDS983087G: UDI/DI each 10193489237351, UDI/DI case 40193489237352, Lot Number: 21LBS976; Medline Kit Number/SKU CDS983087G: UDI/DI each 10193489237351, UDI/DI case 40193489237352, Lot Number: 21VBA210; Medline Kit Number/SKU CDS983087G: UDI/DI each 10193489237351, UDI/DI case 40193489237352, Lot Number: 21IBJ308; Medline Kit Number/SKU CDS983087G: UDI/DI each 10193489237351, UDI/DI case 40193489237352, Lot Number: 21HBH146; Medline Kit Number/SKU CDS983087G: UDI/DI each 10193489237351, UDI/DI case 40193489237352, Lot Number: 21HBH148; Medline Kit Number/SKU CDS983100F: UDI/DI each 10198459479779, UDI/DI case 40198459479770, Lot Number: 25IBD292; Medline Kit Number/SKU CDS983100G: UDI/DI each 10198459579738, UDI/DI case 40198459579739, Lot Number: 25KBO235; Medline Kit Number/SKU CDS983178D: UDI/DI each 10193489577624, UDI/DI case 40193489577625, Lot Number: 22EBC371; Medline Kit Number/SKU CDS983178D: UDI/DI each 10193489577624, UDI/DI case 40193489577625, Lot Number: 22EBD213; Medline Kit Number/SKU CDS983178D: UDI/DI each 10193489577624, UDI/DI case 40193489577625, Lot Number: 22CBL563; Medline Kit Number/SKU CDS983178D: UDI/DI each 10193489577624, UDI/DI case 40193489577625, Lot Number: 22BBA124; Medline Kit Number/SKU CDS983178D: UDI/DI each 10193489577624, UDI/DI case 40193489577625, Lot Number: 21LBG253; Medline Kit Number/SKU CDS983178D: UDI/DI each 10193489577624, UDI/DI case 40193489577625, Lot Number: 21JBO038; Medline Kit Number/SKU CDS983178D: UDI/DI each 10193489577624, UDI/DI case 40193489577625, Lot Number: 21IBT664; Medline Kit Number/SKU CDS983178D: UDI/DI each 10193489577624, UDI/DI case 40193489577625, Lot Number: 21GBN275; Medline Kit Number/SKU CDS983178D: UDI/DI each 10193489577624, UDI/DI case 40193489577625, Lot Number: 21FBC638; Medline Kit Number/SKU CDS983178D: UDI/DI each 10193489577624, UDI/DI case 40193489577625, Lot Number: 21FBC639; Medline Kit Number/SKU CDS983178D: UDI/DI each 10193489577624, UDI/DI case 40193489577625, Lot Number: 21DBC491; Medline Kit Number/SKU CDS983178D: UDI/DI each 10193489577624, UDI/DI case 40193489577625, Lot Number: 21ABO804; Medline Kit Number/SKU CDS983178D: UDI/DI each 10193489577624, UDI/DI case 40193489577625, Lot Number: 21ABP999; Medline Kit Number/SKU CDS983178F: UDI/DI each 10195327164638, UDI/DI case 40195327164639, Lot Number: 22JBC334; Medline Kit Number/SKU CDS983178F: UDI/DI each 10195327164638, UDI/DI case 40195327164639, Lot Number: 22IBC429; Medline Kit Number/SKU CDS983178F: UDI/DI each 10195327164638, UDI/DI case 40195327164639, Lot Number: 22GBB109; Medline Kit Number/SKU CDS983178G: UDI/DI each 10195327261740, UDI/DI case 40195327261741, Lot Number: 22KBO917; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 23KBF403; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 23JBQ340; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 23HBO013; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 23GBI927; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 23GBI251; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 23DBE126; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 23CBG894; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 23BBU908; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 23ABT114; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 23ABD213; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 24FBE957; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 24FBE027; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 24DBJ737; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 24DBB214; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 24BBC965; Medline Kit Number/SKU CDS983178I: UDI/DI each 10195327295264, UDI/DI case 40195327295265, Lot Number: 23LBI653; Medline Kit Number/SKU CDS983290B: UDI/DI each 10889942863921, UDI/DI case 40889942863922, Lot Number: 22KBR856; Medline Kit Number/SKU CDS983290B: UDI/DI each 10889942863921, UDI/DI case 40889942863922, Lot Number: 22GBZ077; Medline Kit Number/SKU CDS983290B: UDI/DI each 10889942863921, UDI/DI case 40889942863922, Lot Number: 21LBV099; Medline Kit Number/SKU CDS983290B: UDI/DI each 10889942863921, UDI/DI case 40889942863922, Lot Number: 21HBN975; Medline Kit Number/SKU CDS983290B: UDI/DI each 10889942863921, UDI/DI case 40889942863922, Lot Number: 21EBK912; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 23KDA782; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 23JDC129; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 23HDA711; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 23GDB168; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 23EDA932; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 23DDA965; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 23BDB455; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 23ADB071; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 22KDB570; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 22HDC010; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 22FDA706; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 22ADB940; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 21LDA922; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 21IDC223; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 21GDB946; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 24LDA156; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 24FDB049; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 24FDA099; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 24EDA004; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 24DDB640; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 24CDB110; Medline Kit Number/SKU CDS983302I: UDI/DI each 10193489425659, UDI/DI case 40193489425650, Lot Number: 24BDA740; Medline Kit Number/SKU CDS983302J: UDI/DI each 10198459221422, UDI/DI case 40198459221423, Lot Number: 25HDA041; Medline Kit Number/SKU CDS983302J: UDI/DI each 10198459221422, UDI/DI case 40198459221423, Lot Number: 25DDA409; Medline Kit Number/SKU CDS983302J: UDI/DI each 10198459221422, UDI/DI case 40198459221423, Lot Number: 25BDB499; Medline Kit Number/SKU CDS983302J: UDI/DI each 10198459221422, UDI/DI case 40198459221423, Lot Number: 25ADB031; Medline Kit Number/SKU CDS983302J: UDI/DI each 10198459221422, UDI/DI case 40198459221423, Lot Number: 25ADA386; Medline Kit Number/SKU CDS983483I: UDI/DI each 10193489919585, UDI/DI case 40193489919586, Lot Number: 23KDB343; Medline Kit Number/SKU CDS983483I: UDI/DI each 10193489919585, UDI/DI case 40193489919586, Lot Number: 23IDC238; Medline Kit Number/SKU CDS983483I: UDI/DI each 10193489919585, UDI/DI case 40193489919586, Lot Number: 23GDB258; Medline Kit Number/SKU CDS983483I: UDI/DI each 10193489919585, UDI/DI case 40193489919586, Lot Number: 23FDA481; Medline Kit Number/SKU CDS983483I: UDI/DI each 10193489919585, UDI/DI case 40193489919586, Lot Number: 23EDC384; Medline Kit Number/SKU CDS983483I: UDI/DI each 10193489919585, UDI/DI case 40193489919586, Lot Number: 23EDA061; Medline Kit Number/SKU CDS983483I: UDI/DI each 10193489919585, UDI/DI case 40193489919586, Lot Number: 23BDB237; Medline Kit Number/SKU CDS983483I: UDI/DI each 10193489919585, UDI/DI case 40193489919586, Lot Number: 22JDC014; Medline Kit Number/SKU CDS983483I: UDI/DI each 10193489919585, UDI/DI case 40193489919586, Lot Number: 22HDB551; Medline Kit Number/SKU CDS983483I: UDI/DI each 10193489919585, UDI/DI case 40193489919586, Lot Number: 22EDB248; Medline Kit Number/SKU CDS983483I: UDI/DI each 10193489919585, UDI/DI case 40193489919586, Lot Number: 24DDA998; Medline Kit Number/SKU CDS983483I: UDI/DI each 10193489919585, UDI/DI case 40193489919586, Lot Number: 24BDC023; Medline Kit Number/SKU CDS983483I: UDI/DI each 10193489919585, UDI/DI case 40193489919586, Lot Number: 24ADB891; Medline Kit Number/SKU CDS983483J: UDI/DI each 10198459000089, UDI/DI case 40198459000080, Lot Number: 26BDB084; Medline Kit Number/SKU CDS983483J: UDI/DI each 10198459000089, UDI/DI case 40198459000080, Lot Number: 26ADA978; Medline Kit Number/SKU CDS983483J: UDI/DI each 10198459000089, UDI/DI case 40198459000080, Lot Number: 25LDB821; Medline Kit Number/SKU CDS983483J: UDI/DI each 10198459000089, UDI/DI case 40198459000080, Lot Number: 25IDA147; Medline Kit Number/SKU CDS983483J: UDI/DI each 10198459000089, UDI/DI case 40198459000080, Lot Number: 25GDA133; Medline Kit Number/SKU CDS983483J: UDI/DI each 10198459000089, UDI/DI case 40198459000080, Lot Number: 25DDB752; Medline Kit Number/SKU CDS983483J: UDI/DI each 10198459000089, UDI/DI case 40198459000080, Lot Number: 25CDA553; Medline Kit Number/SKU CDS983483J: UDI/DI each 10198459000089, UDI/DI case 40198459000080, Lot Number: 25ADA847; Medline Kit Number/SKU CDS983483J: UDI/DI each 10198459000089, UDI/DI case 40198459000080, Lot Number: 24KDA075; Medline Kit Number/SKU CDS983483J: UDI/DI each 10198459000089, UDI/DI case 40198459000080, Lot Number: 24HDB378; Medline Kit Number/SKU CDS983483J: UDI/DI each 10198459000089, UDI/DI case 40198459000080, Lot Number: 24FDB899; Medline Kit Number/SKU CDS983483J: UDI/DI each 10198459000089, UDI/DI case 40198459000080, Lot Number: 24EDA920; Medline Kit Number/SKU CDS983486G: UDI/DI each 10889942946426, UDI/DI case 40889942946427, Lot Number: 21EDB219; Medline Kit Number/SKU CDS983486I: UDI/DI each 10193489917291, UDI/DI case 40193489917292, Lot Number: 23EDC050; Medline Kit Number/SKU CDS983486I: UDI/DI each 10193489917291, UDI/DI case 40193489917292, Lot Number: 23ADB520; Medline Kit Number/SKU CDS983486I: UDI/DI each 10193489917291, UDI/DI case 40193489917292, Lot Number: 22HDB969; Medline Kit Number/SKU CDS983486I: UDI/DI each 10193489917291, UDI/DI case 40193489917292, Lot Number: 22FDB297; Medline Kit Number/SKU CDS983486I: UDI/DI each 10193489917291, UDI/DI case 40193489917292, Lot Number: 22EDB405; Medline Kit Number/SKU CDS983486I: UDI/DI each 10193489917291, UDI/DI case 40193489917292, Lot Number: 22ADA924; Medline Kit Number/SKU CDS983486I: UDI/DI each 10193489917291, UDI/DI case 40193489917292, Lot Number: 21KDC414; Medline Kit Number/SKU CDS983486I: UDI/DI each 10193489917291, UDI/DI case 40193489917292, Lot Number: 21KDA145; Medline Kit Number/SKU CDS983486I: UDI/DI each 10193489917291, UDI/DI case 40193489917292, Lot Number: 21JDA228; Medline Kit Number/SKU CDS983486I: UDI/DI each 10193489917291, UDI/DI case 40193489917292, Lot Number: 21IDA657; Medline Kit Number/SKU CDS983486I: UDI/DI each 10193489917291, UDI/DI case 40193489917292, Lot Number: 21GDC624; Medline Kit Number/SKU CDS983486I: UDI/DI each 10193489917291, UDI/DI case 40193489917292, Lot Number: 21GDB516; Medline Kit Number/SKU CDS983486I: UDI/DI each 10193489917291, UDI/DI case 40193489917292, Lot Number: 21GDB372; Medline Kit Number/SKU CDS983486K: UDI/DI each 10195327497200, UDI/DI case 40195327497201, Lot Number: 23KDB885; Medline Kit Number/SKU CDS983486K: UDI/DI each 10195327497200, UDI/DI case 40195327497201, Lot Number: 23JDA349; Medline Kit Number/SKU CDS983486K: UDI/DI each 10195327497200, UDI/DI case 40195327497201, Lot Number: 24CDB975; Medline Kit Number/SKU CDS983486K: UDI/DI each 10195327497200, UDI/DI case 40195327497201, Lot Number: 24CDA873; Medline Kit Number/SKU CDS983486K: UDI/DI each 10195327497200, UDI/DI case 40195327497201, Lot Number: 24ADB821; Medline Kit Number/SKU CDS983486K: UDI/DI each 10195327497200, UDI/DI case 40195327497201, Lot Number: 24ADA731; Medline Kit Number/SKU CDS983486L: UDI/DI each 10198459000126, UDI/DI case 40198459000127, Lot Number: 24GDA578; Medline Kit Number/SKU CDS983486L: UDI/DI each 10198459000126, UDI/DI case 40198459000127, Lot Number: 24FDB898; Medline Kit Number/SKU CDS983486L: UDI/DI each 10198459000
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Potency or specification failure
out-of-specification