FDA recall Z-2628-2024 — MEDLINE INDUSTRIES, LP - Northfield is recalling See RES description (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
openFDA drug & device enforcement (recall) reports
FDA recall Z-2628-2024: MEDLINE INDUSTRIES, LP - Northfield is recalling See RES description
The FDA logged enforcement record Z-2628-2024: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling See RES description — reason: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-04-08. Affected lots/codes: 00-398650AJ, Lot Number 23ABN193 ; 00-398650AJ, Lot Number 23ABN291 ; 00-398650AJ, Lot Number 23EBQ823 ; 00-398650AJ, Lot Number 23FBJ579 ; 00-398650AJ, Lot Number 23FBT136 ; 00-398650AJ, Lot Number 23IBB919 ; 00-398650AJ, Lot Number 23KBE097 ; 00-398650AJ, Lot Number 23LBS258 ; 00-398725AL, Lot Number 19BBA371 ; 00-398725AL, Lot Number 19CBE645 ; 00-398725AL, Lot Number 19DBR240 ; 00-398725AL, Lot Number 19EBK403 ; 00-398725AL, Lot Number 19FBU700 ; 00-398725AL, Lot Number 19GBR148 ; 00-398725AN, Lot Number 21FBS869 ; 00-398725AN, Lot Number 21JBN432 ; 00-398725AN, Lot Number 21LBK643 ; 00-398725AN, Lot Number 22ABX426 ; 00-398725AN, Lot Number 22BBR469 ; 00-398725AN, Lot Number 22CBU793 ; 00-398725AN, Lot Number 22OBM117 ; 00-398725AN, Lot Number 22EBK111 ; 00-398725AN, Lot Number 22GBJ289 ; 00-398725AN, Lot Number 22IBU378 ; 00-398725AN, Lot Number 22JBV752 ; 00-398725AN, Lot Number 22LBE100 ; 00-398725AN, Lot Number 23ABO369 ; 00-398725AN, Lot Number 23BBT199 ; 00-398725AN, Lot Number 23DBI838 ; 00-398725AN, Lot Number 23EBN543 ; 00-398725AN, Lot Number 23FBJ242 ; 00-398725AN, Lot Number 23HBB887 ; 00-398725AN, Lot Number 23IBG737 ; 00-398725AN, Lot Number 23JBD877 ; 00-398725AN, Lot Number 23KBT703 ; 00-398725AN, Lot Number 23LMC442 ; 00-399024AA, Lot Number 21GBA375 ; 00-399024AA, Lot Number 21HBS579 ; 00-399024AA, Lot Number 21VBC664 ; 00-399024AB, Lot Number 22ABB635 ; 00-399024AB, Lot Number 22BBO663 ; 00-399024AB, Lot Number 22EBG768 ; 00-399024AB, Lot Number 22IBI311 ; 00-399024AB, Lot Number 22JBH694 ; 00-399024AB, Lot Number 22KBU955 ; 00-399024AB, Lot Number 23FBJ294 ; 00-399024AB, Lot Number 23FBJ440 ; 00-399024AB, Lot Number 23KMC721 ; 00-399024Y , Lot Number 20EBH037 ; 00-399024Y , Lot Number 20FBK078 ; 00-399024Y , Lot Number 20GBR534 ; 00-399024Y , Lot Number 21ABP810 ; 00-399024Y , Lot Number 21CBU873 ; 00-399024Y , Lot Number 21EBP778 ; 00-400065L , Lot Number 23DBD207 ; 00-400065L , Lot Number 23EBJ498 ; 00-400065L , Lot Number 23GBJ037 ; 00-400065L , Lot Number 23IBF873 ; 00-400065L , Lot Number 23JBL649 ; 00-400065L , Lot Number 23LBE623 ; 00-400069G , Lot Number 21LBB433 ; 00-400069G , Lot Number 22DBB020 ; 00-400069G , Lot Number 22EBC910 ; 00-400069G , Lot Number 22EBV234 ; 00-400069G , Lot Number 22HBP360 ; 00-400069G , Lot Number 22HBW658 ; 00-400069G , Lot Number 22KBM739 ; 00-400069G , Lot Number 23BBE018 ; 00-400069G , Lot Number 23DBH203 ; 00-400069G , Lot Number 23EBL232 ; 00-400069G , Lot Number 23FBC820 ; 00-400069G , Lot Number 23HBG409 ; 00-400069G , Lot Number 23JBL385 ; 00-400069G , Lot Number 23KBN848 ; 00-400123AF, Lot Number 22JBH530 ; 00-400123AF, Lot Number 22KBD299 ; 00-400123AF, Lot Number 22LBQ546 ; 00-400123AF, Lot Number 23BBB966 ; 00-400123AF, Lot Number 23BBI999 ; 00-400123AF, Lot Number 23DBO192 ; 00-400123AF, Lot Number 23FBL331 ; 00-400123AF, Lot Number 23GBR420 ; 00-400123AF, Lot Number 23HBV016 ; 00-400123AF, Lot Number 23IBG789 ; 00-400123AF, Lot Number 23LBC235 ; 00-400305R , Lot Number 21IBJ826 ; 00-400305R , Lot Number 21KBR458 ; 00-400305R , Lot Number 22CBI724 ; 00-400305R , Lot Number 22EBK662 ; 00-400305R , Lot Number 22IBJ403 ; 00-400305R , Lot Number 22JBD291 ; 00-400305R , Lot Number 22KBK176 ; 00-400305R , Lot Number 23BBV103 ; 00-400305R , Lot Number 23CBL452 ; 00-400305R , Lot Number 23DBQ308 ; 00-400305R , Lot Number 23FBK335 ; 00-400305R , Lot Number 23GBJ895 ; 00-400305R , Lot Number 23IBO701 ; 00-400305R , Lot Number 23JBA168 ; 00-400305R , Lot Number 23JBL386 ; 00-400305R , Lot Number 23LMB829 ; 00-400830R , Lot Number 19ADC720 ; 00-400830R , Lot Number 19CDA813 ; 00-400830R , Lot Number 19DDB497 ; 00-400830R , Lot Number 19FDB937 ; 00-400830R , Lot Number 19HDA442 ; 00-401185P , Lot Number 19CBM890 ; 00-401185P , Lot Number 19EBY268 ; 00-401185P , Lot Number 19FBN514 ; 00-401185P , Lot Number 19GBW615 ; 00-401185P , Lot Number 19TBC327 ; 00-401185P , Lot Number 19IBE749 ; 00-401185P , Lot Number 19WBB156 ; 00-401185P , Lot Number 20BBA469 ; 00-401185P , Lot Number 20BBL762 ; 00-401185P , Lot Number 20GMC079 ; 00-401185P , Lot Number 20JMB009 ; 00-401185P , Lot Number 20LMF711 ; 00-401226L , Lot Number 23CBH251 ; 00-401226L , Lot Number 23DBF510 ; 00-401226M , Lot Number 23EBL561 ; 00-401226M , Lot Number 23FBP809 ; 00-401226M , Lot Number 23HBE389 ; 00-401226M , Lot Number 23JBC640 ; 00-401226M , Lot Number 23KBM570 ; 00-401226M , Lot Number 24ABR599 ; 00-401327AB, Lot Number 22BMG914 ; 00-401327AB, Lot Number 22BMH421 ; 00-401327AB, Lot Number 22CMH580 ; 00-401327AB, Lot Number 22EMB322 ; 00-401327AB, Lot Number 22EMG688 ; 00-401327AB, Lot Number 22FMF299 ; 00-401327AB, Lot Number 22FMF862 ; 00-401327AB, Lot Number 22KMA282 ; 00-401327AC, Lot Number 24ABE391 ; 00-401327AC, Lot Number 22HMB235 ; 00-401327AC, Lot Number 22KMA012 ; 00-401327AC, Lot Number 23BME128 ; 00-401327AC, Lot Number 23CMH564 ; 00-401327AC, Lot Number 23DMI322 ; 00-401327AC, Lot Number 23EMB739 ; 00-401327AC, Lot Number 23FMF497 ; 00-401327AC, Lot Number 23IMD322 ; 00-401327AC, Lot Number 23IMI428 ; 00-401327AC, Lot Number 23JMG156 ; 00-401520I , Lot Number 19BBT175 ; 00-401520I , Lot Number 19EBA310 ; 00-401520I , Lot Number 19FBO245 ; 00-401610J , Lot Number 21HBS574 ; 00-401610J , Lot Number 21KBM779 ; 00-401610J , Lot Number 19ABH550 ; 00-401610J , Lot Number 19ABO523 ; 00-401610J , Lot Number 19CBC978 ; 00-401610J , Lot Number 22DBI169 ; 00-401610J , Lot Number 19DBG949 ; 00-401610J , Lot Number 19QBB050 ; 00-401610J , Lot Number 22GBI926 ; 00-401610J , Lot Number 19FBV889 ; 00-401610J , Lot Number 22HBM305 ; 00-401610J , Lot Number 19SBA979 ; 00-401610J , Lot Number 22IBD386 ; 00-401610J , Lot Number 22JBB059 ; 00-401610J , Lot Number 22KBL665 ; 00-401610J , Lot Number 22LBH626 ; 00-401610J , Lot Number 19JBH949 ; 00-401610J , Lot Number 23BBP435 ; 00-401610J , Lot Number 23DBA375 ; 00-401610J , Lot Number 20ABB642 ; 00-401610J , Lot Number 20ABN964 ; 00-401610J , Lot Number 23EBJ499 ; 00-401610J , Lot Number 23HBV412 ; 00-401610J , Lot Number 20EBL968 ; 00-401610J , Lot Number 23IBJ464 ; 00-401610J , Lot Number 20GBD342 ; 00-401610J , Lot Number 20GBK183 ; 00-401610J , Lot Number 23KBV448 ; 00-401610J , Lot Number 23LBJ940 ; 00-401610J , Lot Number 23LBL085 ; 00-401610J , Lot Number 20JBQ148 ; 00-401610J , Lot Number 20LBA499 ; 00-401610J , Lot Number 20LBX698 ; 00-401610J , Lot Number 21ABV634 ; 00-401610J , Lot Number 21CBM081 ; 00-401610J , Lot Number 21FBE620 ; 00-401724J , Lot Number 19ABZ347 ; 00-401724J , Lot Number 19CBF961 ; 00-401724J , Lot Number 19EBH371 ; 00-401724J , Lot Number 19FBN467 ; 00-401724J , Lot Number 19GBE549 ; 00-401724J , Lot Number 19HBV379 ; 00-401724J , Lot Number 19TBE794 ; 00-401724J , Lot Number 19JBH600 ; 00-401724J , Lot Number 19JBM452 ; 00-401724J , Lot Number 19WBA520 ; 00-401724L , Lot Number 23IBU329 ; 00-401724L , Lot Number 23KBK518 ; 00-401800C , Lot Number 21HBL910 ; 00-401800C , Lot Number 21IBI464 ; 00-401800C , Lot Number 21LBX642 ; 00-401800C , Lot Number 22NBE651 ; 00-401800C , Lot Number 19CBD271 ; 00-401800C , Lot Number 22EBV541 ; 00-401800C , Lot Number 19FBF864 ; 00-401800C , Lot Number 22HBF800 ; 00-401800C , Lot Number 19GBH350 ; 00-401800C , Lot Number 19HBU681 ; 00-401800C , Lot Number 22JBY128 ; 00-401800C , Lot Number 22LBE627 ; 00-401800C , Lot Number 20BBK257 ; 00-401800C , Lot Number 20CBA900 ; 00-401800C , Lot Number 20HBB750 ; 00-401800C , Lot Number 20JBJ126 ; 00-401800C , Lot Number 20KBW671 ; 00-401800C , Lot Number 21CBE761 ; 00-500510G , Lot Number 24BLA035 ; 00-500510G , Lot Number 24BLA084 ; 00-HCT055O , Lot Number 19CBC776 ; 00-HCT055O , Lot Number 19DBQ204 ; 00-HCT055O , Lot Number 19JBF633 ; 00-HCT055O , Lot Number 19LBS053 ; 00-HCT098L , Lot Number 20JMA483 ; 00-HCT098L , Lot Number 20KMD129 ; 00-HCT098L , Lot Number 21AMB411 ; 00-HCT098L , Lot Number 21AMD853 ; 00-HCT098L , Lot Number 21CMA749 ; 00-HCT098L , Lot Number 21EMB764 ; 00-HCT098L , Lot Number 21EME168 ; 00-HCT098L , Lot Number 21FMC561 ; 00-HCT098L , Lot Number 21GMD913 ; 00-HCT098L , Lot Number 21HMG726 ; 00-HCT098L , Lot Number 21KMA569 ; 00-HCT098L , Lot Number 21KMH232 ; 00-HCT098L , Lot Number 21LMG217 ; 00-HCT098L , Lot Number 22AME556 ; 00-HCT098L , Lot Number 22BMA052 ; 00-HCT098L , Lot Number 22CMD434 ; 00-HCT098M , Lot Number 22EMH087 ; 00-HCT098M , Lot Number 22FMF080 ; 00-HCT098M , Lot Number 22FMF083 ; 00-HCT098M , Lot Number 22FMF281 ; 00-HCT098M , Lot Number 22JMF628 ; 00-HCT098M , Lot Number 23AMB918 ; 00-HCT098M , Lot Number 23AMF508 ; 00-HCT098M , Lot Number 23BMC578 ; 00-HCT098M , Lot Number 23CMB179 ; 00-HCT098M , Lot Number 23EMC252 ; 00-HCT098M , Lot Number 23FMA653 ; 00-HCT098N , Lot Number 23GMD007 ; 00-HCT098N , Lot Number 23HMB990 ; 00-HCT098N , Lot Number 23IMI247 ; 00-HCT098N , Lot Number 23KMC200 ; 00-HCT098N , Lot Number 24AMG945 ; 00-QG7623B , Lot Number 21KBR828 ; 00-QG7623B , Lot Number 22BBT754 ; 00-QG7623B , Lot Number 22NBA152 ; 00-QG7623B , Lot Number 19BBC207 ; 00-QG7623B , Lot Number 19JBQ026 ; 00-QG7623B , Lot Number 19KBC731 ; 00-QG7623B , Lot Number 19KBW313 ; 00-QG7623B , Lot Number 19LBQ979 ; 00-QG7623B , Lot Number 23FBL295 ; 00-QG7623B , Lot Number 23HBU832 ; 00-QG7623B , Lot Number 23JBE369 ; 00-QG7623B , Lot Number 20HBH222 ; 00-QG7623B , Lot Number 23LBI499 ; 00-RDF036N , Lot Number 19ADB969 ; 00-RDF036N , Lot Number 19BDD398 ; 00-RDF036N , Lot Number 19DDB358 ; 00-RDF036N , Lot Number 19FMA054 ; 00-RDF036N , Lot Number 19FMA319 ; 00-RDF036N , Lot Number 19HMA429 ; 00-RDF036N , Lot Number 19JMA940 ; 00-RDF036N , Lot Number 19KMB632 ; 00-RDF036N , Lot Number 19LMC962 ; 00-RDF036N , Lot Number 20BMC376 ; 00-RDF036N , Lot Number 20DMB534 ; 00-RDF036N , Lot Number 20GMB529 ; 00-RDF036N , Lot Number 20IMD632 ; 00-RDF036N , Lot Number 20LMF755 ; 00-RDF036N , Lot Number 21CMD573 ; 00-RDF036N , Lot Number 21EMB774 ; 00-RDF036N , Lot Number 21EMD265 ; 00-RDF036N , Lot Number 21GMF652 ; 00-RDF036N , Lot Number 21IMH195 ; 00-RDF036N , Lot Number 21JMI157 ; 00-RDF036N , Lot Number 21KMD161 ; 00-RDF036N , Lot Number 21KMI185 ; 00-RDF036N , Lot Number 22EMD845 ; 00-RDF036O , Lot Number 22FMH197 ; 00-RDF036O , Lot Number 22IMC476 ; 00-RDF036O , Lot Number 22JMD690 ; 00-RDF036O , Lot Number 22KMB816 ; 00-RDF036O , Lot Number 22LMB962 ; 00-RDF036O , Lot Number 23BMA905 ; 00-RDF036O , Lot Number 23BMH681 ; 00-RDF036O , Lot Number 23CMG412 ; 00-RDF036O , Lot Number 23DMI750 ; 00-RDF036O , Lot Number 23IMD552 ; 00-RDF036O , Lot Number 23KMD849 ; 0M-CP30807I, Lot Number 21FBM874 ; 0M-CP30807I, Lot Number 21GBK656 ; 0M-CP30807I, Lot Number 21HBM461 ; 0M-CP30807I, Lot Number 21JBU670 ; 0M-CP30807I, Lot Number 21LBC896 ; 0M-CP30807I, Lot Number 22BBQ169 ; 0M-CP30807I, Lot Number 22BBQ170 ; 0M-CP30807I, Lot Number 22BBQ171 ; 0M-CP30807I, Lot Number 19ABK270 ; 0M-CP30807I, Lot Number 19CBE501 ; 0M-CP30807I, Lot Number 19DBE266 ; 0M-CP30807I, Lot Number 19FBE005 ; 0M-CP30807I, Lot Number 22GBW948 ; 0M-CP30807I, Lot Number 22IBJ821 ; 0M-CP30807I, Lot Number 19HBD698 ; 0M-CP30807I, Lot Number 19IBR533 ; 0M-CP30807I, Lot Number 22LBD825 ; 0M-CP30807I, Lot Number 19JBM781 ; 0M-CP30807I, Lot Number 23ABN452 ; 0M-CP30807I, Lot Number 19KBN641 ; 0M-CP30807I, Lot Number 23BBO112 ; 0M-CP30807I, Lot Number 20BBF567 ; 0M-CP30807I, Lot Number 23FBI142 ; 0M-CP30807I, Lot Number 20CBF202 ; 0M-CP30807I, Lot Number 23HBO781 ; 0M-CP30807I, Lot Number 20EBH584 ; 0M-CP30807I, Lot Number 23JBH835 ; 0M-CP30807I, Lot Number 23KBI383 ; 0M-CP30807I, Lot Number 20IBK266 ; 0M-CP30807I, Lot Number 20JBF041 ; 0M-CP30807I, Lot Number 24ABX214 ; 0M-CP30807I, Lot Number 20KBF154 ; 0M-CP30807I, Lot Number 20XBG278 ; 0M-CP31433J, Lot Number 22HBD664 ; 0M-CP31433J, Lot Number 22IBK695 ; 0M-CP31433J, Lot Number 22JBO868 ; 0M-CP31433J, Lot Number 22KBS466 ; 0M-CP31433J, Lot Number 23ABO391 ; 0M-CP31433J, Lot Number 23BBM747 ; 0M-CP31433J, Lot Number 23DBG678 ; 0M-CP31433J, Lot Number 23FBD966 ; 0M-CP31433J, Lot Number 23GBL370 ; 0M-CP31433J, Lot Number 23IBM899 ; 0M-CP31433J, Lot Number 23JBU662 ; 0M-CP31433J, Lot Number 23LBH443 ; 0M-CP31796Q, Lot Number 21GBS499 ; 0M-CP31796Q, Lot Number 21HBP168 ; 0M-CP31796Q, Lot Number 21HBP169 ; 0M-CP31796Q, Lot Number 21KBA214 ; 0M-CP31796Q, Lot Number 21HBP169A; 0M-CP31796Q, Lot Number 22EBD568 ; 0M-CP31796Q, Lot Number 22GBK761 ; 0M-CP31796Q, Lot Number 22GBZ321 ; 0M-CP31796Q, Lot Number 22GBZ322 ; 0M-CP31796Q, Lot Number 19GBB441 ; 0M-CP31796Q, Lot Number 19GBK978 ; 0M-CP31796Q, Lot Number 19HBD656 ; 0M-CP31796Q, Lot Number 19HBE028 ; 0M-CP31796Q, Lot Number 19HBZ570 ; 0M-CP31796Q, Lot Number 22KBM188 ; 0M-CP31796Q, Lot Number 19JBR459 ; 0M-CP31796Q, Lot Number 22LBS425 ; 0M-CP31796Q, Lot Number 23BBC868 ; 0M-CP31796Q, Lot Number 19KBR284 ; 0M-CP31796Q, Lot Number 23CBV565 ; 0M-CP31796Q, Lot Number 19LBW231 ; 0M-CP31796Q, Lot Number 23DBQ955 ; 0M-CP31796Q, Lot Number 23FBE308 ; 0M-CP31796Q, Lot Number 20CBL148 ; 0M-CP31796Q, Lot Number 23GBG007 ; 0M-CP31796Q, Lot Number 20DBU424 ; 0M-CP31796Q, Lot Number 23IBG393 ; 0M-CP31796Q, Lot Number 23KBI268 ; 0M-CP31796Q, Lot Number 20GBS763 ; 0M-CP31796Q, Lot Number 23LBF360 ; 0M-CP31796Q, Lot Number 20IBJ964 ; 0M-CP31796Q, Lot Number 24ABU569 ; 0M-CP31796Q, Lot Number 20KBL073 ; 0M-CP31796Q, Lot Number 20LBZ094 ; 0M-CP31796Q, Lot Number 21ABE391 ; 0M-CP31796Q, Lot Number 21BBA437 ; 0M-CP31796Q, Lot Number 21CBY817 ; 0M-CP32229G, Lot Number 21IBK605 ; 0M-CP32229G, Lot Number 22ABZ870 ; 0M-CP32229G, Lot Number 22BBS756 ; 0M-CP32229G, Lot Number 19ABQ464 ; 0M-CP32229G, Lot Number 19ABT077 ; 0M-CP32229G, Lot Number 22CBJ834 ; 0M-CP32229G, Lot Number 19BBN315 ; 0M-CP32229G, Lot Number 19EBG599 ; 0M-CP32229G, Lot Number 19EBS788 ; 0M-CP32229G, Lot Number 19FBE818 ; 0M-CP32229G, Lot Number 19KBD372 ; 0M-CP32229G, Lot Number 19LBX119 ; 0M-CP32229G, Lot Number 20CBA605 ; 0M-CP32229G, Lot Number 20CBH115 ; 0M-CP32229G, Lot Number 20CBV201 ; 0M-CP32229G, Lot Number 20EBI007 ; 0M-CP32229G, Lot Number 20HBQ177 ; 0M-CP32229G, Lot Number 21BBE766 ; 0M-CP32229G, Lot Number 21CBN278 ; 60220488 , Lot Number 23LBC519 ; 60220488 , Lot Number 23LBC520 ; 60220488 , Lot Number 23LBD120 ; 65011213 , Lot Number 21VBB006 ; 65030314 , Lot Number 21KBC506 ; 65050346 , Lot Number 21KBD672 ; 65050348 , Lot Number 21VBB007 ; 651202927, Lot Number 21HBN686 ; 65183482 , Lot Number 23LBV434 ; 65220591 , Lot Number 21KBD644 ; AM100A , Lot Number 23BBI938 ; AM100A , Lot Number 23FBB920 ; AM100A , Lot Number 23HBU747 ; AM100A , Lot Number 23IBP414 ; AM100A , Lot Number 23JBT734 ; AM100A , Lot Number 23KBD017 ; AM100A , Lot Number 23LBH485 ; B103A, Lot Number 19KBD622 ; BM17BAD, Lot Number 23DBR020 ; BM17BAD, Lot Number 23KBT845 ; CDS840228F , Lot Number 19ELA497 ; CDS840228F , Lot Number 19GLA250 ; CDS840228F , Lot Number 19HLA532 ; CDS840228F , Lot Number 19ILA236 ; CDS840228F , Lot Number 19KLA440 ; CDS840228F , Lot Number 20ALA827 ; CDS840228F , Lot Number 20DLA403 ; CDS840228F , Lot Number 20HLA172 ; CDS840228F , Lot Number 20JLA448 ; CDS840228F , Lot Number 21CLA101 ; CDS840228F , Lot Number 21CLA103 ; CDS840228F , Lot Number 21CLA496 ; CDS840228F , Lot Number 21DLA748 ; CDS840228F , Lot Number 21FLA030 ; CDS840228F , Lot Number 21GLA177 ; CDS840228F , Lot Number 21ILA915 ; CDS840228F , Lot Number 21JLA316 ; CDS840228F , Lot Number 21JLB170 ; CDS840228F , Lot Number 21LLA196 ; CDS840228F , Lot Number 22ALA369 ; CDS840228F , Lot Number 22ALA597 ; CDS840228F , Lot Number 22CLA155 ; CDS840228F , Lot Number 22CLA726 ; CDS840228F , Lot Number 22ELA137 ; CDS840228F , Lot Number 22FLA788 ; CDS840228F , Lot Number 22GLA774 ; CDS840228F , Lot Number 22ILA363 ; CDS840228F , Lot Number 22KLB047 ; CDS840228F , Lot Number 23ALA133 ; CDS840228F , Lot Number 23CLA672 ; CDS840228F , Lot Number 23CLA832 ; CDS840228F , Lot Number 23ELA032 ; CDS840228F , Lot Number 23FLA055 ; CDS840228F , Lot Number 23FLA663 ; CDS840228F , Lot Number 23FLB058 ; CDS840228F , Lot Number 23HLA405 ; CDS840228F , Lot Number 23JLA368 ; CDS840228F , Lot Number 23JLB175 ; CDS840228F , Lot Number 23KLA901 ; CDS840228F , Lot Number 24ALA584 ; CDS840239T , Lot Number 19BBM889 ; CDS840239T , Lot Number 19DBK159 ; CDS840239T , Lot Number 19FBK737 ; CDS840239T , Lot Number 19GBX148 ; CDS840239T , Lot Number 19IBC627 ; CDS840239T , Lot Number 20ABR717 ; CDS840239T , Lot Number 20CBF526 ; CDS840239T , Lot Number 20DBQ006 ; CDS840239T , Lot Number 20EBI426 ; CDS840239T , Lot Number 20EBS233 ; CDS840362D , Lot Number 21GBA665 ; CDS840362D , Lot Number 21IBA784 ; CDS840362D , Lot Number 22ABV320 ; CDS840362D , Lot Number 19ABO650 ; CDS840362D , Lot Number 19BBQ463 ; CDS840362D , Lot Number 19FBD669 ; CDS840362D , Lot Number 19IBE297 ; CDS840362D , Lot Number 19IBY167 ; CDS840362D , Lot Number 19KBG653 ; CDS840362D , Lot Number 19LBG150 ; CDS840362D , Lot Number 19LBU199 ; CDS840362D , Lot Number 20CBP298 ; CDS840362D , Lot Number 20DBT393 ; CDS840362D , Lot Number 20FBF635 ; CDS840362D , Lot Number 20HBG879 ; CDS840362D , Lot Number 20WBI999 ; CDS840362D , Lot Number 21BBH847 ; CDS840362D , Lot Number 21DBK044 ; CDS840362D , Lot Number 21DBK071 ; CDS840362F , Lot Number 22FBE953 ; CDS840362F , Lot Number 22FBG119 ; CDS840362F , Lot Number 22GBP048 ; CDS840362F , Lot Number 22IBP763 ; CDS840362F , Lot Number 22JBR844 ; 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A RECORDED FDA enforcement action (occurred=true).
openFDA drug & device enforcement (recall) reports — U.S. FDA
A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.
FDA classified recall Z-2628-2024 as Class II
The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
U.S. FDA recall classification (openFDA enforcement)
occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.
A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
a recorded enforcement action, not proof of harm or causation; not medical advice
occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.
Ongoing — the recall is still being carried out.
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
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