Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, P... — FDA record Z-2995-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 8, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401185Q ; 3) PACEMAKER TRAY, Pack Number 00-401521F ; 4) FEMORAL PACK, Pack Number 00-401525G ; 5) CARDIAC CATH PACK , Pack Number 00-401561K ; 6) CORONARY ANGIO PACK-LF, Pack Number 00-401594S ; 7) LEFT HEART TRAY , Pack Number 00-401880I ; 8) EP LAB PACEMAKER PACK , Pack Number 00-401893K ; 9) EP LAB PACEMAKER PACK , Pack Number 00-401893L ; 10) ADVANTEC-MLD, Pack Number 00-500510D ; 11) ADVANTEC-MLD, Pack Number 00-500510F ; 12) KIT ANGIO CSTM-WALKER, Pack Number 129969; 13) DIAGNOSTIC KIT, Pack Number 147943; 14) MSC - CRESCENT MEDICAL, Pack Number 149155; 15) VASC KIT AUGUSTA MED CEN PG , Pack Number 650123111; 16) OPEN HEART CDS, Pack Number CDS840015AK; 17) OPEN HEART CDS, Pack Number CDS840015AL; 18) OPEN HEART CDS, Pack Number CDS840015AM; 19) OPEN HEART CDS, Pack Number CDS840015AN; 20) OPEN HEART CDS, Pack Number CDS840015AO; 21) OPEN HEART CDS, Pack Number CDS840015AP; 22) OPEN HEART CDS, Pack Number CDS840015AQ; 23) OPEN HEART CDS, Pack Number CDS840015AQ; 24) OPEN HEART CDS, Pack Number CDS840016AD; 25) OPEN HEART CDS, Pack Number CDS840016AD; 26) OPEN HEART CDS, Pack Number CDS840023R ; 27) OPEN HEART CDS, Pack Number CDS840023S ; 28) OPEN HEART CDS, Pack Number CDS840023T ; 29) AAA CDS , Pack Number CDS840076AC; 30) OFF PUMP CABG CDS , Pack Number CDS840087AB; 31) OFF PUMP CABG CDS , Pack Number CDS840087AD; 32) OFF PUMP CABG CDS , Pack Number CDS840087AF; 33) OFF PUMP CABG CDS , Pack Number CDS840087AG; 34) OFF PUMP CABG CDS , Pack Number CDS840087AI; 35) OFF PUMP CABG CDS , Pack Number CDS840087AJ; 36) OFF PUMP CABG CDS , Pack Number CDS840087AK; 37) OFF PUMP CABG CDS , Pack Number CDS840087AL; 38) OPEN HEART CDS, Pack Number CDS840094L ; 39) OPEN HEART CDS, Pack Number CDS840094M ; 40) OPEN HEART CDS, Pack Number CDS840094N ; 41) OPEN HEART CDS, Pack Number CDS840094P ; 42) OPEN HEART CDS, Pack Number CDS840108J ; 43) OPEN HEART CDS, Pack Number CDS840108K ; 44) OPEN HEART CDS, Pack Number CDS840132N ; 45) OPEN HEART CDS, Pack Number CDS840132O ; 46) OPEN HEART CDS, Pack Number CDS840144O ; 47) OPEN HEART CDS, Pack Number CDS840144P ; 48) OPEN HEART CDS, Pack Number CDS840144Q ; 49) OPEN HEART CDS, Pack Number CDS840144Q ; 50) OPEN HEART CDS, Pack Number CDS840145S ; 51) OPEN HEART CDS, Pack Number CDS840145T ; 52) OPEN HEART CDS, Pack Number CDS840145U ; 53) OPEN HEART, Pack Number CDS840150R ; 54) OPEN HEART, Pack Number CDS840150S ; 55) OPEN HEART, Pack Number CDS840150T ; 56) OPEN HEART, Pack Number CDS840150U ; 57) OPEN HEART, Pack Number CDS840150V ; 58) PACEMAKER CDS , Pack Number CDS840162S ; 59) PACEMAKER CDS , Pack Number CDS840162T ; 60) PACEMAKER CDS , Pack Number CDS840162U ; 61) PACEMAKER CDS , Pack Number CDS840162V ; 62) OPEN HEART CDS, Pack Number CDS840171AA; 63) OPEN HEART CDS, Pack Number CDS840171AB; 64) OPEN HEART CDS, Pack Number CDS840171AC; 65) OPEN HEART CDS, Pack Number...
Reason
XXX
Classification
Class II
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
Not supplied
Agency-reported status
Ongoing
Source record identifier
Z-2995-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicability00-400361J , Lot Number 19GMA398 ; 00-400361J , Lot Number 19KMB977 ; 00-400361J , Lot Number 20AMB625 ; 00-400361J , Lot Number 20CMB790 ; 00-400361J , Lot Number 20EMB935 ; 00-400361J , Lot Number 20HMD638 ; 00-400361J , Lot Number 20JMF103 ; 00-400361J , Lot Number 20LMD909 ; 00-400361J , Lot Number 21HMA255 ; 00-400361J , Lot Number 21HMD608 ; 00-400361J , Lot Number 21JMG396 ; 00-400361J , Lot Number 21LMF121 ; 00-400361J , Lot Number 22AME293 ; 00-400361J , Lot Number 22BMF391 ; 00-400361J , Lot Number 22HMA827 ; 00-400361J , Lot Number 22LMA159 ; 00-400361J , Lot Number 23CMA918 ; 00-400361J , Lot Number 23EMG313 ; 00-400361J , Lot Number 23HME323 ; 00-400361J , Lot Number 19DKC989 ; 00-400361J , Lot Number 19EKD171 ; 00-401185Q , Lot Number 21BMC803 ; 00-401185Q , Lot Number 21CMB169 ; 00-401185Q , Lot Number 21FME996 ; 00-401185Q , Lot Number 21HMC811 ; 00-401185Q , Lot Number 21JMF649 ; 00-401185Q , Lot Number 22AMB298 ; 00-401185Q , Lot Number 22CMH907 ; 00-401185Q , Lot Number 22EMA951 ; 00-401185Q , Lot Number 22EME874 ; 00-401185Q , Lot Number 22FMF282 ; 00-401185Q , Lot Number 22FMF580 ; 00-401185Q , Lot Number 22HME725 ; 00-401185Q , Lot Number 22IMD217 ; 00-401185Q , Lot Number 22LMA438 ; 00-401185Q , Lot Number 23CMD526 ; 00-401185Q , Lot Number 23EMF518 ; 00-401185Q , Lot Number 23GMD389 ; 00-401185Q , Lot Number 23HMH421 ; 00-401185Q , Lot Number 23IMH814 ; 00-401521F , Lot Number 22CBE464 ; 00-401521F , Lot Number 19BBD936 ; 00-401521F , Lot Number 19EBL198 ; 00-401521F , Lot Number 19WBB570 ; 00-401521F , Lot Number 20EBD061 ; 00-401521F , Lot Number 20EBK193 ; 00-401521F , Lot Number 23JBT733 ; 00-401521F , Lot Number 20LBC052 ; 00-401521F , Lot Number 21ABI211 ; 00-401525G , Lot Number 21GBO675 ; 00-401525G , Lot Number 21IBA321 ; 00-401525G , Lot Number 21JBW514 ; 00-401525G , Lot Number 21LBP821 ; 00-401525G , Lot Number 22BBW574 ; 00-401525G , Lot Number 22CBZ322 ; 00-401525G , Lot Number 22OBD345 ; 00-401525G , Lot Number 19DBA953 ; 00-401525G , Lot Number 22EBS321 ; 00-401525G , Lot Number 19EBX278 ; 00-401525G , Lot Number 19EBX645 ; 00-401525G , Lot Number 19GBK251 ; 00-401525G , Lot Number 19SBD727 ; 00-401525G , Lot Number 22JBF078 ; 00-401525G , Lot Number 22KBQ242 ; 00-401525G , Lot Number 19VBD535 ; 00-401525G , Lot Number 19KBP818 ; 00-401525G , Lot Number 19LBD342 ; 00-401525G , Lot Number 23CBL714 ; 00-401525G , Lot Number 23EBI077 ; 00-401525G , Lot Number 23FBH811 ; 00-401525G , Lot Number 20DBC252 ; 00-401525G , Lot Number 23GBW352 ; 00-401525G , Lot Number 23IBB620 ; 00-401525G , Lot Number 20EBS479 ; 00-401525G , Lot Number 23JBH811 ; 00-401525G , Lot Number 20GBT714 ; 00-401525G , Lot Number 20JBC305 ; 00-401525G , Lot Number 21ABE171 ; 00-401525G , Lot Number 21CBS174 ; 00-401525G , Lot Number 21EBR135 ; 00-401561K , Lot Number 19ABB458 ; 00-401561K , Lot Number 19ABY023 ; 00-401561K , Lot Number 19CBB584 ; 00-401561K , Lot Number 19DBG969 ; 00-401561K , Lot Number 19EBG778 ; 00-401561K , Lot Number 19FBM963 ; 00-401561K , Lot Number 19SBG949 ; 00-401561K , Lot Number 19KBE358 ; 00-401594S , Lot Number 21EDA345 ; 00-401594S , Lot Number 21GDC290 ; 00-401594S , Lot Number 21HDC372 ; 00-401594S , Lot Number 21KDB536 ; 00-401594S , Lot Number 22BDA106 ; 00-401594S , Lot Number 22CDB669 ; 00-401594S , Lot Number 22CDC224 ; 00-401594S , Lot Number 22FDA001 ; 00-401594S , Lot Number 22GDA339 ; 00-401594S , Lot Number 22IDA127 ; 00-401594S , Lot Number 22JDC194 ; 00-401594S , Lot Number 23BDA244 ; 00-401594S , Lot Number 23BDB723 ; 00-401594S , Lot Number 23DDA900 ; 00-401594S , Lot Number 23FDB364 ; 00-401594S , Lot Number 23GDB492 ; 00-401594S , Lot Number 23JDA045 ; 00-401594S , Lot Number 23LDC052 ; 00-401594S , Lot Number 24BDA515 ; 00-401880I , Lot Number 21FBR920 ; 00-401880I , Lot Number 21IBN364 ; 00-401880I , Lot Number 21KBJ427 ; 00-401880I , Lot Number 22ABH895 ; 00-401880I , Lot Number 22BBU351 ; 00-401880I , Lot Number 19ABO520 ; 00-401880I , Lot Number 19DBQ061 ; 00-401880I , Lot Number 22FBO924 ; 00-401880I , Lot Number 19FBM977 ; 00-401880I , Lot Number 19SBF703 ; 00-401880I , Lot Number 22JBC747 ; 00-401880I , Lot Number 22LBO277 ; 00-401880I , Lot Number 22LBO735 ; 00-401880I , Lot Number 22LBP364 ; 00-401880I , Lot Number 19JBV415 ; 00-401880I , Lot Number 20BBE782 ; 00-401880I , Lot Number 20FBH730 ; 00-401880I , Lot Number 23JBI807 ; 00-401880I , Lot Number 23KBP558 ; 00-401880I , Lot Number 20HBW267 ; 00-401880I , Lot Number 21ABE437 ; 00-401880I , Lot Number 21CBB803 ; 00-401880I , Lot Number 21EBB401 ; 00-401893K , Lot Number 19BDA313 ; 00-401893K , Lot Number 19DDC831 ; 00-401893K , Lot Number 19GDA588 ; 00-401893K , Lot Number 19GDC053 ; 00-401893K , Lot Number 19IDA009 ; 00-401893K , Lot Number 19JMB407 ; 00-401893K , Lot Number 19LMA556 ; 00-401893K , Lot Number 20AMC670 ; 00-401893K , Lot Number 20CMA801 ; 00-401893K , Lot Number 20EMA701 ; 00-401893K , Lot Number 20HMD901 ; 00-401893K , Lot Number 21AMA759 ; 00-401893K , Lot Number 21AMC286 ; 00-401893K , Lot Number 21CMB164 ; 00-401893K , Lot Number 21GMD267 ; 00-401893K , Lot Number 21HMF130 ; 00-401893K , Lot Number 21JMB601 ; 00-401893K , Lot Number 21LMF357 ; 00-401893L , Lot Number 23FBM719 ; 00-401893L , Lot Number 23HBR879 ; 00-401893L , Lot Number 23JBX744 ; 00-401893L , Lot Number 24ABQ827 ; 00-401893L , Lot Number 22CMD657 ; 00-401893L , Lot Number 22DMJ075 ; 00-401893L , Lot Number 22IMG828 ; 00-401893L , Lot Number 22JMC769 ; 00-401893L , Lot Number 22KMG913 ; 00-401893L , Lot Number 23AMI218 ; 00-401893L , Lot Number 23CMD959 ; 00-401893L , Lot Number 23EMD512 ; 00-500510D , Lot Number 21FBI165 ; 00-500510D , Lot Number 21FBI418 ; 00-500510D , Lot Number 21GBH514 ; 00-500510D , Lot Number 21GBT047 ; 00-500510D , Lot Number 21HBI423 ; 00-500510D , Lot Number 21IBN225 ; 00-500510D , Lot Number 21VBB295 ; 00-500510D , Lot Number 21KBF665 ; 00-500510D , Lot Number 21KBP859 ; 00-500510D , Lot Number 21LBK037 ; 00-500510D , Lot Number 21LBV855 ; 00-500510D , Lot Number 19ABF836 ; 00-500510D , Lot Number 22BBT369 ; 00-500510D , Lot Number 22BBT370 ; 00-500510D , Lot Number 22BBT373 ; 00-500510D , Lot Number 22NBD250 ; 00-500510D , Lot Number 19ABY556 ; 00-500510D , Lot Number 22CBS531 ; 00-500510D , Lot Number 19CBF033 ; 00-500510D , Lot Number 22OBE487 ; 00-500510D , Lot Number 19CBQ541 ; 00-500510D , Lot Number 19DBC193 ; 00-500510D , Lot Number 19DBV833 ; 00-500510D , Lot Number 19EBO551 ; 00-500510D , Lot Number 22FBR999 ; 00-500510D , Lot Number 19EBZ886 ; 00-500510D , Lot Number 19FBI015 ; 00-500510D , Lot Number 19FBI471 ; 00-500510D , Lot Number 19GBI858 ; 00-500510D , Lot Number 19HBH384 ; 00-500510D , Lot Number 19IBE371 ; 00-500510D , Lot Number 19IBF032 ; 00-500510D , Lot Number 19IBI219 ; 00-500510D , Lot Number 19JBL103 ; 00-500510D , Lot Number 19VBA392 ; 00-500510D , Lot Number 19VBB518 ; 00-500510D , Lot Number 19KBQ007 ; 00-500510D , Lot Number 19KBU914 ; 00-500510D , Lot Number 19LBC188 ; 00-500510D , Lot Number 19LBL331 ; 00-500510D , Lot Number 20ABQ871 ; 00-500510D , Lot Number 20BBU110 ; 00-500510D , Lot Number 20BBY738 ; 00-500510D , Lot Number 20CBL120 ; 00-500510D , Lot Number 20DBA938 ; 00-500510D , Lot Number 20EBN261 ; 00-500510D , Lot Number 20EBQ580 ; 00-500510D , Lot Number 20GBO712 ; 00-500510D , Lot Number 20GBR966 ; 00-500510D , Lot Number 21ABQ685 ; 00-500510D , Lot Number 21BBD205 ; 00-500510D , Lot Number 21DBQ654 ; 00-500510F , Lot Number 22HBU530 ; 00-500510F , Lot Number 22KBB372 ; 00-500510F , Lot Number 23ABD122 ; 00-500510F , Lot Number 23ABE574 ; 00-500510F , Lot Number 23CBG780 ; 00-500510F , Lot Number 23CBJ408 ; 00-500510F , Lot Number 23EBC431 ; 00-500510F , Lot Number 23EBU664 ; 00-500510F , Lot Number 23FBC616 ; 00-500510F , Lot Number 23GBE309 ; 00-500510F , Lot Number 23GBS398 ; 00-500510F , Lot Number 23JBN173 ; 00-500510F , Lot Number 23LBE584 ; 129969, Lot Number 22BBK642; 129969, Lot Number 22IBB549; 147943, Lot Number 24ABU386; 147943, Lot Number 24ABB395; 147943, Lot Number 23LBH739; 147943, Lot Number 23KBW964; 147943, Lot Number 23IBR202; 147943, Lot Number 23IBJ020; 147943, Lot Number 23HBT017; 147943, Lot Number 23HBF624; 147943, Lot Number 23FBN683; 149155, Lot Number 23JBH149; 650123111, Lot Number 21KBZ481 ; 650123111, Lot Number 22OBH018 ; 650123111, Lot Number 22HBF027 ; 650123111, Lot Number 22HBM362 ; 650123111, Lot Number 22IBD609 ; 650123111, Lot Number 22LBJ613 ; 650123111, Lot Number 23EBB875 ; 650123111, Lot Number 23FBM247 ; 650123111, Lot Number 23HBE368 ; 650123111, Lot Number 23KBJ892 ; CDS840015AK, Lot Number 19ABN979 ; CDS840015AK, Lot Number 19BBM872 ; CDS840015AK, Lot Number 19CBC958 ; CDS840015AK, Lot Number 19DBG300 ; CDS840015AL, Lot Number 19FBM446 ; CDS840015AL, Lot Number 19GBR813 ; CDS840015AL, Lot Number 19SBH381 ; CDS840015AL, Lot Number 19HBP412 ; CDS840015AM, Lot Number 19KLA416 ; CDS840015AM, Lot Number 19KLA589 ; CDS840015AM, Lot Number 19LLA500 ; CDS840015AM, Lot Number 20ALA122 ; CDS840015AM, Lot Number 20ALA701 ; CDS840015AN, Lot Number 20BLA588 ; CDS840015AN, Lot Number 20ELA580 ; CDS840015AN, Lot Number 20JLA162 ; CDS840015AN, Lot Number 20JLA716 ; CDS840015AN, Lot Number 20KLA001 ; CDS840015AN, Lot Number 20KLA152 ; CDS840015AO, Lot Number 21ALA434 ; CDS840015AO, Lot Number 21ALA450 ; CDS840015AO, Lot Number 21BLA535 ; CDS840015AO, Lot Number 21CLA241 ; CDS840015AO, Lot Number 21FLA629 ; CDS840015AO, Lot Number 21GLA233 ; CDS840015AO, Lot Number 21GLA426 ; CDS840015AO, Lot Number 21HLA058 ; CDS840015AP, Lot Number 21KLA366 ; CDS840015AP, Lot Number 22ALA405 ; CDS840015AP, Lot Number 22BLA377 ; CDS840015AP, Lot Number 22BLB099 ; CDS840015AP, Lot Number 22DLA779 ; CDS840015AP, Lot Number 22ELA330 ; CDS840015AP, Lot Number 22GLA236 ; CDS840015AP, Lot Number 22GLA758 ; CDS840015AP, Lot Number 22GLB010 ; CDS840015AP, Lot Number 22HLA483 ; CDS840015AQ, Lot Number 22LLA456 ; CDS840015AQ, Lot Number 22LLA822 ; CDS840015AQ, Lot Number 23BLA228 ; CDS840015AQ, Lot Number 23BLA824 ; CDS840015AQ, Lot Number 23DLA416 ; CDS840015AQ, Lot Number 23DLA677 ; CDS840015AQ, Lot Number 23DLB107 ; CDS840015AQ, Lot Number 23ELA682 ; CDS840015AQ, Lot Number 23FLA191 ; CDS840015AQ, Lot Number 23FLA519 ; CDS840015AQ, Lot Number 23GLB212 ; CDS840015AQ, Lot Number 23HLA522 ; CDS840015AQ, Lot Number 23ILA042 ; CDS840015AQ, Lot Number 23JLB173 ; CDS840015AQ, Lot Number 23LLA688 ; CDS840015AQ, Lot Number 24BLA549 ; CDS840015AQ, Lot Number 24CLA640 ; CDS840016AD, Lot Number 21GBE959 ; CDS840016AD, Lot Number 21HBJ898 ; CDS840016AD, Lot Number 21LBH187 ; CDS840016AD, Lot Number 22ABY331 ; CDS840016AD, Lot Number 22DBQ101 ; CDS840016AD, Lot Number 22EBC449 ; CDS840016AD, Lot Number 22FBH312 ; CDS840016AD, Lot Number 22HBM674 ; CDS840016AD, Lot Number 22HBM675 ; CDS840016AD, Lot Number 22IBC587 ; CDS840016AD, Lot Number 19HBO685 ; CDS840016AD, Lot Number 22KBB889 ; CDS840016AD, Lot Number 19JBR664 ; CDS840016AD, Lot Number 19JBW644 ; CDS840016AD, Lot Number 23ABK208 ; CDS840016AD, Lot Number 23CBU665 ; CDS840016AD, Lot Number 23CBV808 ; CDS840016AD, Lot Number 19LBW504 ; CDS840016AD, Lot Number 23EBD314 ; CDS840016AD, Lot Number 23EBG200 ; CDS840016AD, Lot Number 23EBX041 ; CDS840016AD, Lot Number 23FBR732 ; CDS840016AD, Lot Number 20CBN891 ; CDS840016AD, Lot Number 20CBN924 ; CDS840016AD, Lot Number 23HBA346 ; CDS840016AD, Lot Number 23HBY326 ; CDS840016AD, Lot Number 20EBO288 ; CDS840016AD, Lot Number 20EBS065 ; CDS840016AD, Lot Number 23IBO533 ; CDS840016AD, Lot Number 20EBW131 ; CDS840016AD, Lot Number 23JBK436 ; CDS840016AD, Lot Number 20GBA406 ; CDS840016AD, Lot Number 23JBT305 ; CDS840016AD, Lot Number 23JBY115 ; CDS840016AD, Lot Number 23KBJ607 ; CDS840016AD, Lot Number 20HBP261 ; CDS840016AD, Lot Number 20HBQ828 ; CDS840016AD, Lot Number 24ABG468 ; CDS840016AD, Lot Number 20KBX313 ; CDS840016AD, Lot Number 21ABK444 ; CDS840016AD, Lot Number 21DBQ626 ; CDS840016AD, Lot Number 21FBC425 ; CDS840016AD, Lot Number 21FBG949 ; CDS840016AD, Lot Number 24CBF361 ; CDS840023R , L...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution.

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date
Sep 18, 2024
Recall initiation date
Apr 8, 2024
Center classification date
Sep 6, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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