Recall Z-2995-2024— MEDLINE INDUSTRIES, LP - Northfield

Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2024-04-08. FDA's recall record names no specific 510(k) clearance for this event. 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 CDS840171AD; 66) HEART CDS , Pack Number CDS840179M ; 67) HEART CDS, Pack Number CDS840179M ; 68) MINOR VASCULAR PACK , Pack Number CDS840184M ; 69) MINOR VASCULAR PACK , Pack Number CDS840184N ; 70) MINOR VASCULAR PACK , Pack Number CDS840184O ; 71) MINOR VASCULAR PACK, Pack Number CDS840184P; 72) OPEN HEART PACK , Pack Number CDS840185S ; 73) OPEN HEART PACK , Pack Number CDS840185T ; 74) OPEN HEART PACK , Pack Number CDS840185U ; 75) OPEN HEART PACK , Pack Number CDS840185V ; 76) OPEN HEART PACK , Pack Number CDS840185W ; 77) VALVE PACK, Pack Number CDS840187S ; 78) VALVE PACK, Pack Number CDS840187T ; 79) OPEN HEART, Pack Number CDS840189R ; 80) MAJOR VASCULAR, Pack Number CDS840195T ; 81) MAJOR VASCULAR, Pack Number CDS840195U ; 82) CABG-LF , Pack Number CDS840231Q ; 83) CABG-LF , Pack Number CDS840231R ; 84) CABG-LF , Pack Number CDS840231S ; 85) CABG-LF , Pack Number CDS840231T ; 86) MAJOR VASCU. Reason: XXX.

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Classification

Class II

Status

Ongoing

Initiated

2024-04-08

Firm location

Northfield, IL, United States

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