| | Class 2 Device Recall CardinalHealth Preource |  |
| Date Initiated by Firm | May 29, 2024 |
|---|
| Date Posted | July 10, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2327-2024 |
|---|
| Recall Event ID |
94763 |
| Product Classification |
Angiography/angioplasty kit - Product Code OEQ
|
| Product | Presource kits and trays, labeled as:
1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605;
2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606;
3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607;
4) ANGIOGRAPHY PACK, Catalog Number SAN13BS608;
5) ANGIOGRAPHY PACK, Catalog Number SAN13BS609;
6) STERILE ANGIOGRAPHY PACK, Catalog Number SAN13BS60K;
7) ANGIOGRAPHY PACK, Catalog Number SAN13BS60L;
8) ANGIOGRAPHY PACK, Catalog Number SAN13BS60M;
9) ANGIOGRAPHY PACK, Catalog Number SAN13BS60N;
10) ANGIOGRAPHY PACK, Catalog Number SAN13BS60O;
11) CATH LAB PACK, Catalog Number SAN13CLET2;
12) CATH LAB PACK, Catalog Number SAN13CLETC;
13) CATH LAB PACK, Catalog Number SAN13CLETD;
14) ARTERIOGRAM PACK, Catalog Number SAN21AGE10;
15) ARTERIOGRAM PACK, Catalog Number SAN21AGEG6;
16) ARTERIOGRAM PACK, Catalog Number SAN21AGEG7;
17) ARTERIOGRAM PACK, Catalog Number SAN21AGEG8;
18) ARTERIOGRAM PACK, Catalog Number SAN21AGEG9;
19) ARTERIOGRAM PACK, Catalog Number SAN21AGEGJ;
20) ARTERIOGRAM PACK, Catalog Number SAN21AGEGK;
21) ARTERIOGRAM PACK, Catalog Number SAN21AGEGL;
22) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ10;
23) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ11;
24) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ12;
25) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ13;
26) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ14;
27) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ15;
28) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ16;
29) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ17;
30) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ18;
31) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJ19;
32) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC6;
33) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC7;
34) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC8;
35) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJC9;
36) NEURO ARTERIOGRAM PK, Catalog Number SAN21NAJCH;
37) CVL PACK, Catalog Number SAN22CVW12;
38) CVL PACK, Catalog Number SAN22CVW14;
39) CVL PACK, Catalog Number SAN22CVW15;
40) CVL PACK, Catalog Number SAN22CVW16;
41) CVL PACK, Catalog Number SAN22CVW17;
42) CVL PACK, Catalog Number SAN22CVW18;
43) CVL PACK, Catalog Number SAN22CVW19;
44) CVL PACK, Catalog Number SAN22CVW20;
45) CVL PACK, Catalog Number SAN22CVWRK;
46) CVL PACK, Catalog Number SAN22CVWRL;
47) ACCESSORY PACK, Catalog Number SAN37ASMO3;
48) ACCESSORY PACK, Catalog Number SAN37ASMO4;
49) ACCESSORY PACK, Catalog Number SAN37ASMO5;
50) ACCESSORY PACK, Catalog Number SAN37ASMOE;
51) ACCESSORY PACK, Catalog Number SAN37ASMOF;
52) ACCESSORY PACK, Catalog Number SAN37ASMOG;
53) ACCESSORY PACK, Catalog Number SAN37ASMOH;
54) PEDIATRIC CARDIAC CATH PACK, Catalog Number SAN57PD00K;
55) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLS10;
56) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLS11;
57) CATH LAB ACCESSORY TRAY, Catalog Number SAN5BCLSM7;
58) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLSM8;
59) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLSM9;
60) CATH LAB ACCESSORY TRAY, Catalog Number SAN5BCLSMK;
61) CATH LAB ACCESSORY TRAY, Catalog Number SAN5BCLSML;
62) CATH LAB ANGIO TRAY, Catalog Number SAN5BCLSMN;
63) CATH PACK, Catalog Number SAN73CHS10;
64) CATH PACK, Catalog Number SAN73CHS11;
65) CATH PACK, Catalog Number SAN73CHSJ5;
66) CATH PACK, Catalog Number SAN73CHSJ6;
67) CATH PACK, Catalog Number SAN73CHSJ7;
68) CATH PACK, Catalog Number SAN73CHSJ8;
69) CATH PACK, Catalog Number SAN73CHSJ9;
70) CATH PACK, Catalog Number SAN73CHSJJ;
71) CATH PACK, Catalog Number SAN73CHSJK;
72) ANGIOPLASTY PACK, Catalog Number SAN7AAPHSB;
73) ANGIOPLASTY PACK, Catalog Number SAN7AAPHSC;
74) ANGIOGRAPHY SPEC PK, Catalog Number SAN7CAGGR4;
75) ANGIOGRAPHY SPEC PK, Catalog Number SAN7CAGGRJ;
76) ANGIOGRAPHY SPEC PK, Catalog Number SAN7CAGGRK;
77) ANGIOGRAPHY DRAPE PACK CMC, Catalog Number SANCGADA13;
78) ANGIOGRAPHY DRAPE PACK CMC, Catalog Number SANCGADA14;
79) ANGIOGRAPHY DRAPE PACK CMC, Catalog Number SANCGADA15;
80) ANGIOGRAPHY DRAPE PACK CMC, |
|---|
| Code Information |
1) SAN13BS605, UDI/DI (CS/EA) 50888439661574/10888439661576, Lot Numbers: 358969;
2) SAN13BS606, UDI/DI (CS/EA) 50195594317339/10195594317331, Lot Numbers: 683419;
3) SAN13BS607, UDI/DI (CS/EA) 50195594746986/10195594746988, Lot Numbers: 866520;
4) SAN13BS608, UDI/DI (CS/EA) 50195594778772/10195594778774, Lot Numbers: 887311;
5) SAN13BS609, UDI/DI (CS/EA) 50197106253227/10197106253229, Lot Numbers: 39241;
6) SAN13BS60K, UDI/DI (CS/EA) 50887488801436/10887488801438, Lot Numbers: 229810, 262632, 276480, 297564;
7) SAN13BS60L, UDI/DI (CS/EA) 50888439596357/10888439596359, Lot Numbers: 317663, 375743, 413389, 430039, 456790, 480663, 505742, 530846, 555938, 578665, 608032, 616691, 636514, 660643, 689306;
8) SAN13BS60M, UDI/DI (CS/EA) 50195594473073/10195594473075, Lot Numbers: 750483, 766968, 785075;
9) SAN13BS60N, UDI/DI (CS/EA) 50195594635730/10195594635732, Lot Numbers: 814888, 832379, 893931;
10) SAN13BS60O, UDI/DI (CS/EA) 50195594796813/10195594796815, Lot Numbers: 14519, 55994, 72799, 82775, 89384, 111731, 114055, 131433, 156021, 177997, 213162, 264000, 911967, 930128, 950922, 971740, 991212;
11) SAN13CLET2, UDI/DI (CS/EA) 50197106250646/10197106250648, Lot Numbers: 36883;
12) SAN13CLETC, UDI/DI (CS/EA) 50888439268834/10888439268836, Lot Numbers: 230539, 246895, 287853, 327203, 347971, 369115, 410044, 436785, 465770, 485295, 497198, 509738, 546865, 568745;
13) SAN13CLETD, UDI/DI (CS/EA) 50195594942180/10195594942182, Lot Numbers: 10433, 41607, 68974, 111579, 111828, 120719, 132413, 140179, 187403, 195808, 247166, 267724, 280164, 606687, 636751, 664029, 688523, 714600, 735582, 770617, 803844, 827746, 845899, 861463, 890708, 894367, 906005, 923315, 944987, 952212, 989195;
14) SAN21AGE10, UDI/DI (CS/EA) 50197106258901/10197106258903, Lot Numbers: 40930;
15) SAN21AGEG6, UDI/DI (CS/EA) 50195594092663/10195594092665, Lot Numbers: 619968;
16) SAN21AGEG7, UDI/DI (CS/EA) 50195594489784/10195594489786, Lot Numbers: 743830;
17) SAN21AGEG8, UDI/DI (CS/EA) 50195594524362/10195594524364, Lot Numbers: 760050;
18) SAN21AGEG9, UDI/DI (CS/EA) 50197106068760/10197106068762, Lot Numbers: 958044;
19) SAN21AGEGJ, UDI/DI (CS/EA) 50195594004093/10195594004095, Lot Numbers: 653986, 666654, 702552, 767979, 806380, 817797, 831491, 848171, 870905, 888329, 908189, 925092;
20) SAN21AGEGK, UDI/DI (CS/EA) 50197106074945/10197106074947, Lot Numbers: 16107, 62787, 95786, 123784, 123815, 143550, 170317, 969373, 982319, 998196;
21) SAN21AGEGL, UDI/DI (CS/EA) 50197106455522/10197106455524, Lot Numbers: 227400, 248353, 259022, 277966;
22) SAN21NAJ10, UDI/DI (CS/EA) 50195594610515/10195594610517, Lot Numbers: 803145;
23) SAN21NAJ11, UDI/DI (CS/EA) 50195594669612/10195594669614, Lot Numbers: 826839;
24) SAN21NAJ12, UDI/DI (CS/EA) 50195594787071/10195594787073, Lot Numbers: 890454;
25) SAN21NAJ13, UDI/DI (CS/EA) 50195594870766/10195594870768, Lot Numbers: 915174;
26) SAN21NAJ14, UDI/DI (CS/EA) 50197106037780/10197106037782, Lot Numbers: 941597;
27) SAN21NAJ15, UDI/DI (CS/EA) 50197106108060/10197106108062, Lot Numbers: 972928;
28) SAN21NAJ16, UDI/DI (CS/EA) 50197106136353/10197106136355, Lot Numbers: 987075;
29) SAN21NAJ17, UDI/DI (CS/EA) 50197106289943/10197106289945, Lot Numbers: 50947;
30) SAN21NAJ18, UDI/DI (CS/EA) 50197106327300/10197106327302, Lot Numbers: 66821;
31) SAN21NAJ19, UDI/DI (CS/EA) 50197106410590/10197106410592, Lot Numbers: 107016;
32) SAN21NAJC6, UDI/DI (CS/EA) 50195594214058/10195594214050, Lot Numbers: 650449;
33) SAN21NAJC7, UDI/DI (CS/EA) 50195594323309/10195594323301, Lot Numbers: 683284;
34) SAN21NAJC8, UDI/DI (CS/EA) 50195594503442/10195594503444, Lot Numbers: 748742;
35) SAN21NAJC9, UDI/DI (CS/EA) 50195594525444/10195594525446, Lot Numbers: 759388;
36) SAN21NAJCH, UDI/DI (CS/EA) 50195594957849/10195594957841, Lot Numbers: 130141, 225181, 227211, 252404;
37) SAN22CVW12, UDI/DI (CS/EA) 50195594859396/10195594859398, Lot Numbers: 914634;
38) SAN22CVW14, UDI/DI (CS/EA) 50197106118496/10197106118498, Lot Numbers: 979530;
39) SAN22CVW15, UDI/DI (CS/EA) 50197106292387/10197106292389, Lot Numbers: 54624;
40) SAN22CVW16, UDI/DI (CS/EA) 50197106378166/10197106378168, Lot Numbers: 91797;
41) SAN22CVW17, UDI/DI (CS/EA) 50197106380855/10197106380857, Lot Numbers: 93517;
42) SAN22CVW18, UDI/DI (CS/EA) 50197106420070/10197106420072, Lot Numbers: 113807;
43) SAN22CVW19, UDI/DI (CS/EA) 50197106446056/10197106446058, Lot Numbers: 129896;
44) SAN22CVW20, UDI/DI (CS/EA) 50197106520855/10197106520857, Lot Numbers: 186939;
45) SAN22CVWRK, UDI/DI (CS/EA) 50195594611581/10195594611583, Lot Numbers: 5852, 23902, 41861, 140670, 154227, 172485, 927707, 958373, 989749, 996690;
46) SAN22CVWRL, UDI/DI (CS/EA) 50197106563401/10197106563403, Lot Numbers: 221129, 236549;
47) SAN37ASMO3, UDI/DI (CS/EA) 50195594456694/10195594456696, Lot Numbers: 728175;
48) SAN37ASMO4, UDI/DI (CS/EA) 50195594649461/10195594649463, Lot Numbers: 817180;
49) SAN37ASMO5, UDI/DI (CS/EA) 50195594678058/10195594678050, Lot Numbers: 834017;
50) SAN37ASMOE, UDI/DI (CS/EA) 50888439271858/10888439271850, Lot Numbers: 231050, 272697, 304203, 337561, 361334, 374047, 404273;
51) SAN37ASMOF, UDI/DI (CS/EA) 50888439794678/10888439794670, Lot Numbers: 425986, 451839, 472968, 491554, 538007, 571527, 595688, 633448, 653939, 675666, 697430, 760614, 791123, 851651, 876985, 913881, 936605, 957258, 979334;
52) SAN37ASMOG, UDI/DI (CS/EA) 50197106122981/10197106122983, Lot Numbers: 3807, 28744, 48028, 72836;
53) SAN37ASMOH, UDI/DI (CS/EA) 50197106350902/10197106350904, Lot Numbers: 96874, 129504, 166973, 184309, 203792, 218690, 228918, 246193, 268437;
54) SAN57PD00K, UDI/DI (CS/EA) 50195594793058/10195594793050, Lot Numbers: 25504, 42250, 84745, 107010, 121665, 145947, 156920;
55) SAN5BCLS10, UDI/DI (CS/EA) 50195594434791/10195594434793, Lot Numbers: 721166;
56) SAN5BCLS11, UDI/DI (CS/EA) 50195594485557/10195594485559, Lot Numbers: 741232;
57) SAN5BCLSM7, UDI/DI (CS/EA) 50888439669761/10888439669763, Lot Numbers: 366522;
58) SAN5BCLSM8, UDI/DI (CS/EA) 50195594202642/10195594202644, Lot Numbers: 648983;
59) SAN5BCLSM9, UDI/DI (CS/EA) 50195594382566/10195594382568, Lot Numbers: 698988;
60) SAN5BCLSMK, UDI/DI (CS/EA) 50888439230329/10888439230321, Lot Numbers: 231983, 254781, 283063, 299671, 334750, 344689, 403812, 418589, 431114, 444005, 491105, 502065, 513154, 534399, 559861;
61) SAN5BCLSML, UDI/DI (CS/EA) 50195594931320/10195594931322, Lot Numbers: 581440;
62) SAN5BCLSMN, UDI/DI (CS/EA) 50195594064844/10195594064846, Lot Numbers: 628969, 630087, 677383, 769024, 790249, 821783, 836924, 863422, 876889, 916451, 929050, 960172, 970962, 970984, 990675, 996059;
63) SAN73CHS10, UDI/DI (CS/EA) 50197106011483/ 0197106011485, Lot Numbers: 928873;
64) SAN73CHS11, UDI/DI (CS/EA) 50197106234134/10197106234136, Lot Numbers: 33743;
65) SAN73CHSJ5, UDI/DI (CS/EA) 50195594414946/10195594414948, Lot Numbers: 713075;
66) SAN73CHSJ6, UDI/DI (CS/EA) 50197106021987/10197106021989, Lot Numbers: 934300;
67) SAN73CHSJ7, UDI/DI (CS/EA) 50195594522757/10195594522759, Lot Numbers: 758996;
68) SAN73CHSJ8, UDI/DI (CS/EA) 50195594822321/10195594822323, Lot Numbers: 904557;
69) SAN73CHSJ9, UDI/DI (CS/EA) 50195594898616/10195594898618, Lot Numbers: 924563;
70) SAN73CHSJJ, UDI/DI (CS/EA) 50888439989500/10888439989502, Lot Numbers: 600640, 631948, 643749, 673661, 783542, 810742, 835551, 849558, 871180, 894682, 942716, 958087, 967193;
71) SAN73CHSJK, UDI/DI (CS/EA) 50197106105526/10197106105528, Lot Numbers: 6595, 43048, 80329, 94861, 106286, 119205, 133307, 150774, 161644, 182516, 219131, 254189, 264478, 280219, 982435, 997043;
72) SAN7AAPHSB, UDI/DI (CS/EA) 50195594057112/10195594057114, Lot Numbers: 748698, 803052;
73) SAN7AAPHSC, UDI/DI (CS/EA) 50195594420916/10195594420918, Lot Numbers: 7199, 14110, 43508, 45954, 67278, 95220, 191372, 213611, 247815, 826776, 835862, 840520, 974661;
74) SAN7CAGGR4, UDI/DI (CS/EA) 50195594526373/10195594526375, Lot Numbers: 760019;
75) SAN7CAGGRJ, UDI/DI (CS/EA) 50195594094339/10195594094331, Lot Numbers: 728464, 764589, 779672, 850059;
76) SAN7CAGGRK, UDI/DI (CS/EA) 50195594714558/10195594714550, Lot Numbers: 26767, 112526, 254843, 917521, 941243, 954047;
77) SANCGADA13, UDI/DI (CS/EA) 50197106311538/10197106311530, Lot Numbers: 506693;
78) SANCGADA14, UDI/DI (CS/EA) 50197106382620/10197106382622, Lot Numbers: 507442;
79) SANCGADA15, UDI/DI (CS/EA) 50197106395491/10197106395493, Lot Numbers: 507547;
80) SANCGADA16, UDI/DI (CS/EA) 50197106582785/10197106582787, Lot Numbers: 510247;
81) SANCGADACC, UDI/DI (CS/EA) 50195594513069/10195594513061, Lot Numbers: 504556, 505054, 505508, 506081, 506339, 508144, 509198, 509199, 509539, 510457, 511246, 511396, 511418, 511584;
82) SANDHCCCFD, UDI/DI (CS/EA) 50197106084142/10197106084144, Lot Numbers: 10737, 23074, 30848, 989938;
83) SANDHCCCFE, UDI/DI (CS/EA) 50197106269242/10197106269244, Lot Numbers: 49746, 60490, 65227, 73529, 87442, 102389, 114050, 144089, 159636, 175216, 192787, 211938, 234735, 238834, 265475;
84) SANOCCPJC1, UDI/DI (CS/EA) 50195594511874/10195594511876, Lot Numbers: 752887;
85) SANOCCPJC2, UDI/DI (CS/EA) 50197106425952/10197106425954, Lot Numbers: 116410;
86) SANOCCPJCG, UDI/DI (CS/EA) 50195594383440/10195594383442, Lot Numbers: 1433, 20410, 37915, 58904, 68192, 78018, 97437, 107018, 127227, 157650, 175561, 700700, 713935, 716576, 728845, 792092, 816966, 822861, 843711, 862089, 891362, 904697, 920727, 938081, 962614, 978544;
87) SANOCIRRS1, UDI/DI (CS/EA) 50195594421296/10195594421298, Lot Numbers: 713853;
88) SANOCIRRSA, UDI/DI (CS/EA) 50888439938140/10888439938142, Lot Numbers: 540460;
89) SANOCIRRSB, UDI/DI (CS/EA) 50195594128744/10195594128746, Lot Numbers: 640781, 784368;
90) SBA73SPVL7, UDI/DI (CS/EA) 50195594806406/10195594806408, Lot Numbers: 899809;
91) SBA73SPVL8, UDI/DI (CS/EA) 50197106242849/10197106242841, Lot Numbers: 35869;
92) SBA73SPVL9, UDI/DI (CS/EA) 50197106536085/10197106536087, Lot Numbers: 197579;
93) SBA73SPVLF, UDI/DI (CS/EA) 50885425845208/10885425845200, Lot Numbers: 16155, 63787, 99032, 143098, 170409, 240762, 241499, 245278, 247305, 276504, 293596, 309173, 337182, 361886, 410637, 439268, 459834, 497113, 526505, 539785, 566502, 578842, 608338, 636714, 663417, 697261, 727520, 734984, 750996, 775553, 807173, 828718, 844150, 874016, 925273, 954345, 972344, 994876;
94) SCV56RH113, UDI/DI (CS/EA) 50888439908105/10888439908107, Lot Numbers: 497961;
95) SCV56RH114, UDI/DI (CS/EA) 50888439939789/10888439939781, Lot Numbers: 516490;
96) SCV56RH115, UDI/DI (CS/EA) 50888439971840/10888439971842, Lot Numbers: 542923;
97) SCV56RH116, UDI/DI (CS/EA) 50195594953209/10195594953201, Lot Numbers: 573745;
98) SCV56RH117, UDI/DI (CS/EA) 50195594016737/10195594016739, Lot Numbers: 599634;
99) SCV56RH118, UDI/DI (CS/EA) 50195594073815/10195594073817, Lot Numbers: 616652;
100) SCV56RH119, UDI/DI (CS/EA) 50195594142672/10195594142674, Lot Numbers: 633862;
101) SCV56RH120, UDI/DI (CS/EA) 50195594278272/10195594278274, Lot Numbers: 670289;
102) SCV56RH121, UDI/DI (CS/EA) 50195594432858/10195594432850, Lot Numbers: 719026;
103) SCV56RH122, UDI/DI (CS/EA) 50195594558732/10195594558734, Lot Numbers: 775188;
104) SCV56RH123, UDI/DI (CS/EA) 50195594578532/10195594578534, Lot Numbers: 784811;
105) SCV56RH124, UDI/DI (CS/EA) 50195594643728/10195594643720, Lot Numbers: 814250;
106) SCV56RH125, UDI/DI (CS/EA) 50195594682246/10195594682248, Lot Numbers: 834779;
107) SCV56RH126, UDI/DI (CS/EA) 50195594716330/10195594716332, Lot Numbers: 849448;
108) SCV56RH127, UDI/DI (CS/EA) 50195594783271/10195594783273, Lot Numbers: 888743;
109) SCV56RH128, UDI/DI (CS/EA) 50197106124862/10197106124864, Lot Numbers: 982198;
110) SCV56RH19V, UDI/DI (CS/EA) 50887488885283/10887488885285, Lot Numbers: 220166, 253448, 285427, 321675, 341181, 373264, 395352, 403333, 470216, 697534, 742395, 903600, 929653.948079 |
Recalling Firm/
Manufacturer |
Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
|
| For Additional Information Contact | customer service
800-551-0533 |
|---|
Manufacturer Reason
for Recall | Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical supplied finished kits. Merit Medical supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a Merit Medical kit component, cannot be distributed for use as they could contain a significant change or modification in design which could significantly alter the safety or effectiveness of the finished kit product, resulting in the risk of patient harm such as inaccurate dosing and a leaking device. |
|---|
FDA Determined
Cause 2 | Device Design |
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| Action | Cardinal Health issued an URGENT: PRODUCT RECALL notice to its consignees on 05/28/2024 via letter. The notice explained the issue, potential risks involved, and requested the following:
"If you locate affected product within your facility, please complete the following:
1. QUARANTINE affected kits & ALERT your clinicians of this action
2. AFFIX a WARNING LABEL to the front of each Presource kit so that it is clearly visible to clinicians, instructing them to remove and discard all syringes within the affected Merit Medical kit in the Presource product.
3. RETURN a copy of the enclosed Acknowledgment Form confirming your receipt of this action and the completion of labeling product via fax to 614.652.9648.
Additional labels will be sent to your facility upon request. Please send an email to:
gmb-FieldCorrectiveAction@cardinalhealth.com
For component credit or replacement, please contact the following:
" Hospitals Cardinal Customer Service at 866.551.0533
" Distributors Distributor Management at 800.635.6021
" Federal Government facilities Government Customer Service at 800.444.1166
If you are a Distributor and have further distributed affected kits, please notify your customers of this recall."
Expansion letter was sent via FedEx Express on 6/20/2024 |
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| Quantity in Commerce | 136753 units |
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| Distribution | Nationwide |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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