Recall archive / FDA device enforcement
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
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 00-400361J , 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.