| | Class 2 Device Recall |  |
| Date Initiated by Firm | November 17, 2022 |
|---|
| Date Posted | February 06, 2023 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1067-2023 |
|---|
| Recall Event ID |
91386 |
| Product Classification |
Cardiovascular procedure kit - Product Code OEZ
|
| Product | Sterile Procedural Trays, labeled as the following:
a. EP LAB PACEMAKER PACK
b. OPEN HEART CDS
c. OPEN HEART CDS
d. AAA CDS
e. OPEN HEART CDS
f. PACEMAKER CDS
g. HEART CDS
h. VALVE PACK
i. OPEN HEART CDS-3
j. OPEN HEART PACK
k. OPEN HEART PACK
l. OPEN HEART ADULT
m. OPEN HEART CDS PART A
n. GLENNON OPEN HEART CDS
o. OPEN HEART CDS
p. MEMORIAL MED CTR BYPASS
q. OPEN HEART PEDS
r. OPEN HEART CDS-4
s. OPEN HEART
t. CAB CDS
u. VASCULAR CDS
v. VALVE CDS
w. OPEN HEART PACK-LF
x. VASCULAR CDS-LF
y. OPEN HEART B CDS-LF
z. CRANIOTOMY CDS
aa. OPEN UROLOGY CDS-LF
bb. TOTAL KNEE CDS
cc. LOWER EXTREMITY CDS-LF
dd. LAMINECTOMY CDS
ee. ENDOVASCULAR CDS
ff. VASCULAR
gg. VASCULAR CDS-3
hh. VASCULAR ACCESS CDS
ii. ZALE PUMP CDS
jj. CUH ENDOVASCULAR CDS
kk. CUH MINOR VASCULAR CDS
ll. FHT CVOR CABG
mm. OPEN HEART CDS
nn. OPEN HEART CDS
oo. CAROTID ENDARTERECTOMY CDS-LF
pp. PACER CDS
qq. PERIPHERAL VASCULAR CDS
rr. ACH OPEN HEART
ss. ACH OPEN HEART
tt. OPEN HEART CDS
uu. VASCULAR CDS
vv. CV CDS
ww. OPEN HEART CABG PACK-LF
xx. MAJOR VASCULAR PACK-LF
yy. CARDIOVASCULAR PACK-LF
zz. VASCULAR HARPER PACK-LF
aaa. CABG 1 OR 2 HARPER PACK
bbb. TAVR 1 PACK-LF
ccc. ENDO VASCULAR PACK-LF
ddd. OPEN HEART A & B PACK
eee. PACEMAKER IMPLANT PACK-LF
fff. PERIPHERAL VASCULAR PACK-LF
ggg. PACEMAKER PACK-LF
hhh. RR-NEURO VASCULAR PACK-LF
iii. CARDIAC CHEST PACK 80701
jjj. OPEN HEART PACK-LF
kkk. PACEMAKER PACK-LF
lll. CARDIOVASCULAR PACK-LF
mmm. OPEN HEART PACK A & B
nnn. MINOR VASCULAR PACK
ooo. OPEN HEART PACK-LF
ppp. SMALL VASCULAR PACK-LF
qqq. MAJOR VASCULAR PACK-LF
rrr. PEDIATRIC CARDIAC PACK-LF
sss. OH VALVE PACK-LF
ttt. HEART OVERHEAD TABLE PACK
uuu. OPEN HEART PACK
vvv. PACEMAKER PACK-LF
www. VASCULAR PACK-LF
xxx. OPEN HEART PACK
yyy. VASCULAR PACK
zzz. CV BASIC SET UP PACK
aaaa. UNIVERSAL OPEN HEART PACK
bbbb. VASCULAR BYPASS PACK-LF
cccc. BMC CABG PACK A
dddd. CUSTOM CAROTID
eeee. A-V FISTULA PACK-LF
ffff. PERIPHERAL VASCULAR PACK-LF
gggg. ECMO PACK
hhhh. HEART PACK
iiii. CABG PACK A&B
jjjj. OPEN HEART PACK
kkkk. CV A & B
llll. PEDIATRIC OPEN HEART-NS-LF
mmmm. PACEMAKER NORTH
nnnn. OPEN HEART PACK
oooo. SVMMC CORE OPEN HEART PACK-LF
pppp. PACEMAKER TRAY-LF
qqqq. PACEMAKER PACK
rrrr. MAJOR VASCULAR-RF-LF
ssss. AV FISTULA-LF
tttt. PACEMAKER PACK
uuuu. VASCULAR PACK
vvvv. PACEMAKER
wwww. MAJOR VASCULAR PACK
xxxx. MAJOR VASCULAR PACK
yyyy. VASCULAR PACK
zzzz. PACEMAKER PACK-LF
aaaaa. RRMC CABG AUXILIARY TRAY
bbbbb. RRMC OPEN HEART PACK
ccccc. MAJOR VASCULAR PACK
ddddd. PACEMAKER PACK
eeeee. PACEMAKER TRAY
fffff. PACEMAKER PACK
ggggg. PACEMAKER PACK
hhhhh. AV FISTULA PK-LF
iiiii. FHT PACER PACK
jjjjj. PACEMAKER SET UP PACK
kkkkk. MAJOR VASCULAR PACK
lllll. PACEMAKER PACK-LF
mmmmm. CAROTID PACK
nnnnn. MAJOR VASCULAR PACK
ooooo. VASCULAR PACK GH-LF
ppppp. A-V FISTULA PACK GH-LF
qqqqq. VASCULAR PACK MH-LF
rrrrr. PACEMAKER PACK L J
sssss. OPEN HEART
ttttt. OPEN HEART SUPPLY TRAY
uuuuu. PACEMAKER PACK
vvvvv. PACEMAKER PACK
wwwww. VASCULAR PACK
xxxxx. BASIC OPEN HEART PACK A B
yyyyy. VASCULAR PACK
zzzzz. OPEN HEART TRAY A-LF
aaaaaa. VASCULAR PACK
bbbbbb. PACEMAKER PACK
cccccc. OPEN HEART PACK
dddddd. ENDOVASCULAR PACK-LF
eeeeee. VASCULAR PACK-LF
ffffff. BASIC OPEN HEART PACK-LF
gggggg. OPEN VASCULAR PACK-LF
hhhhhh. PK, EP LAB PACEMAKER
iiiiii. PK, OPEN HEART-CABG
jjjjjj. OPEN HEART PACK
kkkkkk. PK, OPEN HEART- A&B
llllll. SVMMC VASCULAR MAJOR PACK
mmmmmm. CV PACK
nnnnnn. OPEN HEART PACK A AND B
oooooo. SVMMC CAROTID PACK
pppppp. PK, OPEN HEART-CABG A&B
qqqqqq. PK, OPEN HEART-A&B
rrrrrr. VASCULAR PACK
ssssss. PK, OPEN HEART
tttttt. PK, OPEN HEART
uuuuuu. OPEN HEART PACK
vvvvvv. PK, OPEN HEART-A&B
wwwwww. OPEN HEART PACK
xxxxxx. PK, OPEN HEART-CABG
yyyyyy. PK, OPEN HEART
zzzzzz. CASTRO CABG-COMPONENT PACK
aaaaaaa. RE-ENTRY PACK
bbbbbbb. HEART PACK
ccccccc. OPEN HEART SUPPLY PACK
ddddddd. PK, OPEN HEART-CABG
eeeeeee. CABG PROCEDURE PACK
fffffff. CABG PACK
ggggggg. PK, OPEN HEART
hhhhhhh. VASCULAR GRAFT PACK
iiiiiii. PK, OPEN HEART
jjjjjjj. VASCULAR PACK
kkkkkkk. PK, |
|---|
| Code Information |
a. EP LAB PACEMAKER PACK, Item Number: 00-401893L, Case UDI/GTIN: 40195327127887, Unit UDI/GTIN: 10195327127886, Lot Number: 22JMC769;
b. OPEN HEART CDS, Item Number: CDS840016AD, Case UDI/GTIN: 40193489741842, Unit UDI/GTIN: 10193489741841, Lot Number: 22KBB889;
c. OPEN HEART CDS, Item Number: CDS840023T, Case UDI/GTIN: 40193489682060, Unit UDI/GTIN: 10193489682069, Lot Number: 22JBU353,22JBT770;
d. AAA CDS, Item Number: CDS840076AC, Case UDI/GTIN: 40195327209620, Unit UDI/GTIN: 10195327209629, Lot Number: 22KBE518;
e. OPEN HEART CDS, Item Number: CDS840094N, Case UDI/GTIN: 40195327089512, Unit UDI/GTIN: 10195327089511, Lot Number: 22JBI258,22IBF817;
f. PACEMAKER CDS, Item Number: CDS840162V, Case UDI/GTIN: 40193489480628, Unit UDI/GTIN: 10193489480627, Lot Number: 22KBG388,22IBP339;
g. HEART CDS, Item Number: CDS840179M, Case UDI/GTIN: 40889942894001, Unit UDI/GTIN: 10889942894000, Lot Number: 22JBJ710,22IBQ944;
h. VALVE PACK, Item Number: CDS840187T, Case UDI/GTIN: 40193489816465, Unit UDI/GTIN: 10193489816464, Lot Number: 22JMG653;
i. OPEN HEART CDS-3, Item Number: CDS840246N, Case UDI/GTIN: 40889942217428, Unit UDI/GTIN: 10889942217427, Lot Number: 22JLB009,22JLA126,22ILB075;
j. OPEN HEART PACK, Item Number: CDS840332Y, Case UDI/GTIN: 40195327259298, Unit UDI/GTIN: 10195327259297, Lot Number: 22KLA079;
k. OPEN HEART PACK, Item Number: CDS840393M, Case UDI/GTIN: 40195327188543, Unit UDI/GTIN: 10195327188542, Lot Number: 22KBD842;
l. OPEN HEART ADULT, Item Number: CDS840396X, Case UDI/GTIN: 40193489461917, Unit UDI/GTIN: 10193489461916, Lot Number: 22JBG072,22JBG077,22JBG079;
m. OPEN HEART CDS PART A, Item Number: CDS840402AG, Case UDI/GTIN: 40195327255115, Unit UDI/GTIN: 10195327255114, Lot Number: 22JLA474;
n. GLENNON OPEN HEART CDS, Item Number: CDS840412N, Case UDI/GTIN: 40195327072231, Unit UDI/GTIN: 10195327072230, Lot Number: 22JBG206;
o. OPEN HEART CDS, Item Number: CDS840483K, Case UDI/GTIN: 40888277749796, Unit UDI/GTIN: 10888277749795, Lot Number: 22IBR228;
p. MEMORIAL MED CTR BYPASS, Item Number: CDS901660, Case UDI/GTIN: 40888277814111, Unit UDI/GTIN: 10888277814110, Lot Number: 22KBA999,22JBL553;
q. OPEN HEART PEDS, Item Number: CDS981050Q, Case UDI/GTIN: 40889942864660, Unit UDI/GTIN: 10889942864669, Lot Number: 22JBH010,22IBC746,22IBC748;
r. OPEN HEART CDS-4, Item Number: CDS981159J, Case UDI/GTIN: 40889942215110, Unit UDI/GTIN: 10889942215119, Lot Number: 22JLA895,22ILA228;
s. OPEN HEART, Item Number: CDS981161AB, Case UDI/GTIN: 40193489817462, Unit UDI/GTIN: 10193489817461, Lot Number: 22JBT785;
t. CAB CDS, Item Number: CDS981533G, Case UDI/GTIN: 40195327171422, Unit UDI/GTIN: 10195327171421, Lot Number: 22JBW502;
u. VASCULAR CDS, Item Number: CDS981545F, Case UDI/GTIN: 40193489975407, Unit UDI/GTIN: 10193489975406, Lot Number: 22JBU076,22JBU077;
v. VALVE CDS, Item Number: CDS981551D, Case UDI/GTIN: 40195327171439, Unit UDI/GTIN: 10195327171438, Lot Number: 22JBR297,22IBS787;
w. OPEN HEART PACK-LF, Item Number: CDS981662J, Case UDI/GTIN: 40195327014538, Unit UDI/GTIN: 10195327014537, Lot Number: 22JBV196;
x. VASCULAR CDS-LF, Item Number: CDS982412O, Case UDI/GTIN: 40195327212378, Unit UDI/GTIN: 10195327212377, Lot Number: 22IBB001,22IBB003;
y. OPEN HEART B CDS-LF, Item Number: CDS982423L, Case UDI/GTIN: 40193489419802, Unit UDI/GTIN: 10193489419801, Lot Number: 22JBQ337;
z. CRANIOTOMY CDS, Item Number: CDS982480P, Case UDI/GTIN: 40195327195671, Unit UDI/GTIN: 10195327195670, Lot Number: 22IDB602;
aa. OPEN UROLOGY CDS-LF, Item Number: CDS982482I, Case UDI/GTIN: 40195327071777, Unit UDI/GTIN: 10195327071776, Lot Number: 22JDB005,22IDB497;
bb. TOTAL KNEE CDS, Item Number: CDS982486M, Case UDI/GTIN: 40195327092345, Unit UDI/GTIN: 10195327092344, Lot Number: 22KDA380;
cc. LOWER EXTREMITY CDS-LF, Item Number: CDS982489J, Case UDI/GTIN: 40195327090754, Unit UDI/GTIN: 10195327090753, Lot Number: 22JDB330,22IDB911;
dd. LAMINECTOMY CDS, Item Number: CDS982491Q, Case UDI/GTIN: 40195327195725, Unit UDI/GTIN: 10195327195724, Lot Number: 22JDB539,22JDA137;
ee. ENDOVASCULAR CDS, Item Number: CDS982659M, Case UDI/GTIN: 40193489204187, Unit UDI/GTIN: 10193489204186, Lot Number: 22KLA219,22JLB019,22ILB085;
ff. VASCULAR, Item Number: CDS982699J, Case UDI/GTIN: 40193489418102, Unit UDI/GTIN: 10193489418101, Lot Number: 22KBB744,22KBB751,22KBB749;
gg. VASCULAR CDS-3, Item Number: CDS983002D, Case UDI/GTIN: 40889942000433, Unit UDI/GTIN: 10889942000432, Lot Number: 22JLA875,22ILA255;
hh. VASCULAR ACCESS CDS, Item Number: CDS983105D, Case UDI/GTIN: 40193489635509, Unit UDI/GTIN: 10193489635508, Lot Number: 22JBC333;
ii. ZALE PUMP CDS, Item Number: CDS983187G, Case UDI/GTIN: 40195327258529, Unit UDI/GTIN: 10195327258528, Lot Number: 22JBX916;
jj. CUH ENDOVASCULAR CDS, Item Number: CDS983192G, Case UDI/GTIN: 40193489699068, Unit UDI/GTIN: 10193489699067, Lot Number: 22JBF027,22HBY314;
kk. CUH MINOR VASCULAR CDS, Item Number: CDS983196G, Case UDI/GTIN: 40195327164660, Unit UDI/GTIN: 10195327164669, Lot Number: 22JBT201,22IBB523;
ll. FHT CVOR CABG, Item Number: CDS983346I, Case UDI/GTIN: 40193489929332, Unit UDI/GTIN: 10193489929331, Lot Number: 22IBU546;
mm. OPEN HEART CDS, Item Number: CDS983451Q, Case UDI/GTIN: 40195327165186, Unit UDI/GTIN: 10195327165185, Lot Number: 22JBY402;
nn. OPEN HEART CDS, Item Number: CDS983513F, Case UDI/GTIN: 40193489843720, Unit UDI/GTIN: 10193489843729, Lot Number: 22IBD426;
oo. CAROTID ENDARTERECTOMY CDS-LF, Item Number: CDS983637I, Case UDI/GTIN: 40195327228126, Unit UDI/GTIN: 10195327228125, Lot Number: 22KBC672;
pp. PACER CDS, Item Number: CDS983686I, Case UDI/GTIN: 40193489852982, Unit UDI/GTIN: 10193489852981, Lot Number: 22JBL438,22IBU735;
qq. PERIPHERAL VASCULAR CDS, Item Number: CDS983723I, Case UDI/GTIN: 40195327228157, Unit UDI/GTIN: 10195327228156, Lot Number: 22JBR360,22IBP608;
rr. ACH OPEN HEART, Item Number: CDS983773I, Case UDI/GTIN: 40193489847124, Unit UDI/GTIN: 10193489847123, Lot Number: 22IBJ338;
ss. ACH OPEN HEART, Item Number: CDS983773J, Case UDI/GTIN: 40195327233618, Unit UDI/GTIN: 10195327233617, Lot Number: 22JBH775;
tt. OPEN HEART CDS, Item Number: CDS984355G, Case UDI/GTIN: 40193489484633, Unit UDI/GTIN: 10193489484632, Lot Number: 22JLB146,22ILB092,22ILA721;
uu. VASCULAR CDS, Item Number: CDS985215D, Case UDI/GTIN: 40195327110797, Unit UDI/GTIN: 10195327110796, Lot Number: 22IBR023,22IBA153;
vv. CV CDS, Item Number: CDS985395D, Case UDI/GTIN: 40193489859714, Unit UDI/GTIN: 10193489859713, Lot Number: 22JBI301,22IBU577;
ww. OPEN HEART CABG PACK-LF, Item Number: DYNJ0149567C, Case UDI/GTIN: 40195327235520, Unit UDI/GTIN: 10195327235529, Lot Number: 22IBD436;
xx. MAJOR VASCULAR PACK-LF, Item Number: DYNJ0151111B, Case UDI/GTIN: 40889942050797, Unit UDI/GTIN: 10889942050796, Lot Number: 22IDB491,22IDA147;
yy. CARDIOVASCULAR PACK-LF, Item Number: DYNJ0160327B, Case UDI/GTIN: 40889942051770, Unit UDI/GTIN: 10889942051779, Lot Number: 22JDA346;
zz. VASCULAR HARPER PACK-LF, Item Number: DYNJ0160636F, Case UDI/GTIN: 40193489205566, Unit UDI/GTIN: 10193489205565, Lot Number: 22IDA733,22HDC250;
aaa. CABG 1 OR 2 HARPER PACK, Item Number: DYNJ0160742D, Case UDI/GTIN: 40195327005970, Unit UDI/GTIN: 10195327005979, Lot Number: 22IDB925,22HDA618;
bbb. TAVR 1 PACK-LF, Item Number: DYNJ0170415G, Case UDI/GTIN: 40195327167685, Unit UDI/GTIN: 10195327167684, Lot Number: 22HMD027;
ccc. ENDO VASCULAR PACK-LF, Item Number: DYNJ0236704N, Case UDI/GTIN: 40193489720670, Unit UDI/GTIN: 10193489720679, Lot Number: 22IME561;
ddd. OPEN HEART A & B PACK, Item Number: DYNJ0236832P, Case UDI/GTIN: 40193489404631, Unit UDI/GTIN: 10193489404630, Lot Number: 22HMB796;
eee. PACEMAKER IMPLANT PACK-LF, Item Number: DYNJ0373237M, Case UDI/GTIN: 40193489369015, Unit UDI/GTIN: 10193489369014, Lot Number: 22JBO014;
fff. PERIPHERAL VASCULAR PACK-LF, Item Number: DYNJ0375688L, Case UDI/GTIN: 40193489724258, Unit UDI/GTIN: 10193489724257, Lot Number: 22JBI091;
ggg. PACEMAKER PACK-LF, Item Number: DYNJ0378729F, Case UDI/GTIN: 40888277763310, Unit UDI/GTIN: 10888277763319, Lot Number: 22IMB260;
hhh. RR-NEURO VASCULAR PACK-LF, Item Number: DYNJ0394874L, Case UDI/GTIN: 40193489800006, Unit UDI/GTIN: 10193489800005, Lot Number: 22GLB222;
iii. CARDIAC CHEST PACK 80701, Item Number: DYNJ04439N, Case UDI/GTIN: 40195327160303, Unit UDI/GTIN: 10195327160302, Lot Number: 22JBI819;
jjj. OPEN HEART PACK-LF, Item Number: DYNJ04506V, Case UDI/GTIN: 40193489510318, Unit UDI/GTIN: 10193489510317, Lot Number: 22JMC546;
kkk. PACEMAKER PACK-LF, Item Number: DYNJ04516N, Case UDI/GTIN: 40888277744517, Unit UDI/GTIN: 10888277744516, Lot Number: 22JMH689,22IMF834;
lll. CARDIOVASCULAR PACK-LF, Item Number: DYNJ04676T, Case UDI/GTIN: 40193489805742, Unit UDI/GTIN: 10193489805741, Lot Number: 22JMD285;
mmm. OPEN HEART PACK A & B, Item Number: DYNJ04822R, Case UDI/GTIN: 40195327188178, Unit UDI/GTIN: 10195327188177, Lot Number: 22JBC142;
nnn. MINOR VASCULAR PACK, Item Number: DYNJ04852O, Case UDI/GTIN: 40193489303897, Unit UDI/GTIN: 10193489303896, Lot Number: 22IMF450;
ooo. OPEN HEART PACK-LF, Item Number: DYNJ0530912AK, Case UDI/GTIN: 40195327167661, Unit UDI/GTIN: 10195327167660, Lot Number: 22IBO170;
ppp. SMALL VASCULAR PACK-LF, Item Number: DYNJ0536987AC, Case UDI/GTIN: 40195327170616, Unit UDI/GTIN: 10195327170615, Lot Number: 22JMF083;
qqq. MAJOR VASCULAR PACK-LF, Item Number: DYNJ0536993AI, Case UDI/GTIN: 40195327167630, Unit UDI/GTIN: 10195327167639, Lot Number: 22IBG292;
rrr. PEDIATRIC CARDIAC PACK-LF, Item Number: DYNJ0537013AA, Case UDI/GTIN: 40195327167678, Unit UDI/GTIN: 10195327167677, Lot Number: 22JMC081;
sss. OH VALVE PACK-LF, Item Number: DYNJ0541850O, Case UDI/GTIN: 40195327167654, Unit UDI/GTIN: 10195327167653, Lot Number: 22IBS422;
ttt. HEART OVERHEAD TABLE PACK, Item Number: DYNJ0778508I, Case UDI/GTIN: 40195327049462, Unit UDI/GTIN: 10195327049461, Lot Number: 22IME042;
uuu. OPEN HEART PACK, Item Number: DYNJ0826299T, Case UDI/GTIN: 40193489377980, Unit UDI/GTIN: 10193489377989, Lot Number: 22IBB762,22HBO328;
vvv. PACEMAKER PACK-LF, Item Number: DYNJ0826630L, Case UDI/GTIN: 40195327177073, Unit UDI/GTIN: 10195327177072, Lot Number: 22IMH402,22IMF458;
www. VASCULAR PACK-LF, Item Number: DYNJ0901358J, Case UDI/GTIN: 40195327156559, Unit UDI/GTIN: 10195327156558, Lot Number: 22IDA821;
xxx. OPEN HEART PACK, Item Number: DYNJ0911264O, Case UDI/GTIN: 40195327124329, Unit UDI/GTIN: 10195327124328, Lot Number: 22IBQ743,22HBY040;
yyy. VASCULAR PACK, Item Number: DYNJ14078F, Case UDI/GTIN: 40193489927840, Unit UDI/GTIN: 10193489927849, Lot Number: 22IBI839;
zzz. CV BASIC SET UP PACK, Item Number: DYNJ14224F, Case UDI/GTIN: 40193489927680, Unit UDI/GTIN: 10193489927689, Lot Number: 22JBS669;
aaaa. UNIVERSAL OPEN HEART PACK, Item Number: DYNJ14225F, Case UDI/GTIN: 40888277944078, Unit UDI/GTIN: 10888277944077, Lot Number: 22HBG261;
bbbb. VASCULAR BYPASS PACK-LF, Item Number: DYNJ17470G, Case UDI/GTIN: 40195327224555, Unit UDI/GTIN: 10195327224554, Lot Number: 22JBW106,22JBD564,22IBM206;
cccc. BMC CABG PACK A, Item Number: DYNJ17475J, Case UDI/GTIN: 40195327224807, Unit UDI/GTIN: 10195327224806, Lot Number: 22IBN857,22IBA835,22HBO577,22HBP255;
dddd. CUSTOM CAROTID, Item Number: DYNJ20266K, Case UDI/GTIN: 40195327052943, Unit UDI/GTIN: 10195327052942, Lot Number: 22IBJ739;
eeee. A-V FISTULA PACK-LF, Item Number: DYNJ20502P, Case UDI/GTIN: 40195327024414, Unit UDI/GTIN: 10195327024413, Lot Number: 22JDB304,22IDC077,22IDA958,22IDA175;
ffff. PERIPHERAL VASCULAR PACK-LF, Item Number: DYNJ20503P, Case UDI/GTIN: 40195327024605, Unit UDI/GTIN: 10195327024604, Lot Number: 22IDA018;
gggg. ECMO PACK, Item Number: DYNJ21245N, Case UDI/GTIN: 40193489935708, Unit UDI/GTIN: 10193489935707, Lot Number: 22JBM468,22HBQ114;
hhhh. HEART PACK, Item Number: DYNJ21246P, Case UDI/GTIN: 40193489935715, Unit UDI/GTIN: 10193489935714, Lot Number: 22HBK069;
iiii. CABG PACK A&B, Item Number: DYNJ21971AD, Case UDI/GTIN: 40195327227051, Unit UDI/GTIN: 10195327227050, Lot Number: 22JDA281,22IDA306;
jjjj. OPEN HEART PACK, Item Number: DYNJ22035K, Case UDI/GTIN: 40889942029052, Unit UDI/GTIN: 10889942029051, Lot Number: 22IBQ625,22IBE372,22HBT001;
kkkk. CV A & B, Item Number: DYNJ22215M, Case UDI/GTIN: 40195327058068, Unit UDI/GTIN: 10195327058067, Lot Number: 22HDB323;
llll. PEDIATRIC OPEN HEART-NS-LF, Item Number: DYNJ22230Q, Case UDI/GTIN: 40193489962728, Unit UDI/GTIN: 10193489962727, Lot Number: 22IBQ407,22HBP292,22HBP293,22HBP295;
mmmm. PACEMAKER NORTH, Item Number: DYNJ22388F, Case UDI/GTIN: 40889942598510, Unit UDI/GTIN: 10889942598519, Lot Number: 22HBX429;
nnnn. OPEN HEART PACK, Item Number: DYNJ22851D, Case UDI/GTIN: 40884389685229, Unit UDI/GTIN: 10884389685228, Lot Number: 22HBP275;
oooo. SVMMC CORE OPEN HEART PACK-LF, Item Number: DYNJ22971T, Case UDI/GTIN: 40195327136834, Unit UDI/GTIN: 10195327136833, Lot Number: 22IBO902;
pppp. PACEMAKER TRAY-LF, Item Number: DYNJ23050C, Case UDI/GTIN: 40193489948449, Unit UDI/GTIN: 10193489948448, Lot Number: 22JMG953,22IMI497,22IMB289;
qqqq. PACEMAKER PACK, Item Number: DYNJ24836M, Case UDI/GTIN: 40889942532477, Unit UDI/GTIN: 10889942532476, Lot Number: 22JBK563;
rrrr. MAJOR VASCULAR-RF-LF, Item Number: DYNJ24932P, Case UDI/GTIN: 40195327160150, Unit UDI/GTIN: 10195327160159, Lot Number: 22IBT463;
ssss. AV FISTULA-LF, Item Number: DYNJ24944K, Case UDI/GTIN: 40195327045310, Unit UDI/GTIN: 10195327045319, Lot Number: 22IBO282;
tttt. PACEMAKER PACK, Item Number: DYNJ25865F, Case UDI/GTIN: 40193489387095, Unit UDI/GTIN: 10193489387094, Lot Number: 22JBJ504,22JBK347,22IBU602;
uuuu. VASCULAR PACK, Item Number: DYNJ27559O, Case UDI/GTIN: 40195327155507, Unit UDI/GTIN: 10195327155506, Lot Number: 22JBS418;
vvvv. PACEMAKER, Item Number: DYNJ27798D, Case UDI/GTIN: 40889942000532, Unit UDI/GTIN: 10889942000531, Lot Number: 22JBI655;
wwww. MAJOR VASCULAR PACK, Item Number: DYNJ31398M, Case UDI/GTIN: 40193489735001, Unit UDI/GTIN: 10193489735000, Lot Number: 22ILA207;
xxxx. MAJOR VASCULAR PACK, Item Number: DYNJ31398N, Case UDI/GTIN: 40195327259281, Unit UDI/GTIN: 10195327259280, Lot Number: 22JLA632,22JLA374;
yyyy. VASCULAR PACK, Item Number: DYNJ31902L, Case UDI/GTIN: 40193489776073, Unit UDI/GTIN: 10193489776072, Lot Number: 22IBU515,22HBR178;
zzzz. PACEMAKER PACK-LF, Item Number: DYNJ33062B, Case UDI/GTIN: 40884389604732, Unit UDI/GTIN: 10884389604731, Lot Number: 22HBY351;
aaaaa. RRMC CABG AUXILIARY TRAY, Item Number: DYNJ33387I, Case UDI/GTIN: 40193489915557, Unit UDI/GTIN: 10193489915556, Lot Number: 22JBF985;
bbbbb. RRMC OPEN HEART PACK, Item Number: DYNJ33394M, Case UDI/GTIN: 40193489918640, Unit UDI/GTIN: 10193489918649, Lot Number: 22JBT973,22HBF896;
ccccc. MAJOR VASCULAR PACK, Item Number: DYNJ34102D, Case UDI/GTIN: 40193489551953, Unit UDI/GTIN: 10193489551952, Lot Number: 22IME737;
ddddd. PACEMAKER PACK, Item Number: DYNJ35201I, Case UDI/GTIN: 40195327134113, Unit UDI/GTIN: 10195327134112, Lot Number: 22JBO409;
eeeee. PACEMAKER TRAY, Item Number: DYNJ35519F, Case UDI/GTIN: 40193489809221, Unit UDI/GTIN: 10193489809220, Lot Number: 22JMG600;
fffff. PACEMAKER PACK, Item Number: DYNJ36025C, Case UDI/GTIN: 40193489700269, Unit UDI/GTIN: 10193489700268, Lot Number: 22JMI234;
ggggg. PACEMAKER PACK, Item Number: DYNJ36312K, Case UDI/GTIN: 40195327156436, Unit UDI/GTIN: 10195327156435, Lot Number: 22JMA898;
hhhhh. AV FISTULA PK-LF, Item Number: DYNJ36735D, Case UDI/GTIN: 40195327147229, Unit UDI/GTIN: 10195327147228, Lot Number: 22IBJ526;
iiiii. FHT PACER PACK, Item Number: DYNJ37114G, Case UDI/GTIN: 40193489932080, Unit UDI/GTIN: 10193489932089, Lot Number: 22JBO139,22IBS426;
jjjjj. PACEMAKER SET UP PACK, Item Number: DYNJ38232, Case UDI/GTIN: 40884389685762, Unit UDI/GTIN: 10884389685761, Lot Number: 22JBV577;
kkkkk. MAJOR VASCULAR PACK, Item Number: DYNJ38318F, Case UDI/GTIN: 40193489728515, Unit UDI/GTIN: 10193489728514, Lot Number: 22IME581,22IME054;
lllll. PACEMAKER PACK-LF, Item Number: DYNJ38702, Case UDI/GTIN: 40884389709062, Unit UDI/GTIN: 10884389709061, Lot Number: 22HDB882;
mmmmm. CAROTID PACK, Item Number: DYNJ39488I, Case UDI/GTIN: 40195327249510, Unit UDI/GTIN: 10195327249519, Lot Number: 22IMD856;
nnnnn. MAJOR VASCULAR PACK, Item Number: DYNJ39542F, Case UDI/GTIN: 40193489987646, Unit UDI/GTIN: 10193489987645, Lot Number: 22JMB308,22IMC327;
ooooo. VASCULAR PACK GH-LF, Item Number: DYNJ39840C, Case UDI/GTIN: 40195327177080, Unit UDI/GTIN: 10195327177089, Lot Number: 22IMD146,22IMD147;
ppppp. A-V FISTULA PACK GH-LF, Item Number: DYNJ39861C, Case UDI/GTIN: 40195327176830, Unit UDI/GTIN: 10195327176839, Lot Number: 22JME917;
qqqqq. VASCULAR PACK MH-LF, Item Number: DYNJ39866C, Case UDI/GTIN: 40195327176342, Unit UDI/GTIN: 10195327176341, Lot Number: 22IMH447,22HMH464;
rrrrr. PACEMAKER PACK L J, Item Number: DYNJ40024B, Case UDI/GTIN: 40195327176496, Unit UDI/GTIN: 10195327176495, Lot Number: 22JME764,22IMG357,22HMD989,22GMA585;
sssss. OPEN HEART, Item Number: DYNJ40976A, Case UDI/GTIN: 40889942431213, Unit UDI/GTIN: 10889942431212, Lot Number: 22JLA725;
ttttt. OPEN HEART SUPPLY TRAY, Item Number: DYNJ41007A, Case UDI/GTIN: 40193489305211, Unit UDI/GTIN: 10193489305210, Lot Number: 22IBN535,22IBE489;
uuuuu. PACEMAKER PACK, Item Number: DYNJ41094, Case UDI/GTIN: 40884389896168, Unit UDI/GTIN: 10884389896167, Lot Number: 22JBJ333;
vvvvv. PACEMAKER PACK, Item Number: DYNJ41189, Case UDI/GTIN: 40884389898254, Unit UDI/GTIN: 10884389898253, Lot Number: 22JBO177;
wwwww. VASCULAR PACK, Item Number: DYNJ41397C, Case UDI/GTIN: 40888277950871, Unit UDI/GTIN: 10888277950870, Lot Number: 22HBY320;
xxxxx. BASIC OPEN HEART PACK A B, Item Number: DYNJ41485, Case UDI/GTIN: 40884389909585, Unit UDI/GTIN: 10884389909584, Lot Number: 22JBQ405,22IBK720,22IBA814;
yyyyy. VASCULAR PACK, Item Number: DYNJ41519A, Case UDI/GTIN: 40888277935243, Unit UDI/GTIN: 10888277935242, Lot Number: 22IBR239,22HBT658;
zzzzz. OPEN HEART TRAY A-LF, Item Number: DYNJ42156, Case UDI/GTIN: 40884389913957, Unit UDI/GTIN: 10884389913956, Lot Number: 22JBC984,22IBQ308,22IBH233;
aaaaaa. VASCULAR PACK, Item Number: DYNJ42554B, Case UDI/GTIN: 40889942158332, Unit UDI/GTIN: 10889942158331, Lot Number: 22IBO207;
bbbbbb. PACEMAKER PACK, Item Number: DYNJ42557B, Case UDI/GTIN: 40889942135807, Unit UDI/GTIN: 10889942135806, Lot Number: 22JBJ624,22HBZ316;
cccccc. OPEN HEART PACK, Item Number: DYNJ42580C, Case UDI/GTIN: 40889942816386, Unit UDI/GTIN: 10889942816385, Lot Number: 22HBV705;
dddddd. ENDOVASCULAR PACK-LF, Item Number: DYNJ42831F, Case UDI/GTIN: 40193489880329, Unit UDI/GTIN: 10193489880328, Lot Number: 22JBA341,22IBG065;
eeeeee. VASCULAR PACK-LF, Item Number: DYNJ42849C, Case UDI/GTIN: 40889942849544, Unit UDI/GTIN: 10889942849543, Lot Number: 22IBG029;
ffffff. BASIC OPEN HEART PACK-LF, Item Number: DYNJ43399I, Case UDI/GTIN: 40195327209385, Unit UDI/GTIN: 10195327209384, Lot Number: 22JBI149;
gggggg. OPEN VASCULAR PACK-LF, Item Number: DYNJ43414D, Case UDI/GTIN: 40195327136681, Unit UDI/GTIN: 10195327136680, Lot Number: 22JMB316;
hhhhhh. PK, EP LAB PACEMAKER, Item Number: DYNJ43663A, Case UDI/GTIN: 40193489793681, Unit UDI/GTIN: 10193489793680, Lot Number: 22JBO225;
iiiiii. PK, OPEN HEART-CABG, Item Number: DYNJ43666C, Case UDI/GTIN: 40193489793674, Unit UDI/GTIN: 10193489793673, Lot Number: 22JBT937;
jjjjjj. OPEN HEART PACK, Item Number: DYNJ43741B, Case UDI/GTIN: 40889942821076, Unit UDI/GTIN: 10889942821075, Lot Number: 22HBO045;
kkkkkk. PK, OPEN HEART- A&B, Item Number: DYNJ43751F, Case UDI/GTIN: 40193489414517, Unit UDI/GTIN: 10193489414516, Lot Number: 22IBO181;
llllll. SVMMC VASCULAR MAJOR PACK, Item Number: DYNJ43777J, Case UDI/GTIN: 40193489990189, Unit UDI/GTIN: 10193489990188, Lot Number: 22JBJ507,22IBV692,22IBE494;
mmmmmm. CV PACK, Item Number: DYNJ43824, Case UDI/GTIN: 40888277071729, Unit UDI/GTIN: 10888277071728, Lot Number: 22JMC590,22IMD149,22HMD629;
nnnnnn. OPEN HEART PACK A AND B, Item Number: DYNJ43858B, Case UDI/GTIN: 40195327200191, Unit UDI/GTIN: 10195327200190, Lot Number: 22IBH029,22HBI610;
oooooo. SVMMC CAROTID PACK, Item Number: DYNJ43861F, Case UDI/GTIN: 40193489981644, Unit UDI/GTIN: 10193489981643, Lot Number: 22JBL517;
pppppp. PK, OPEN HEART-CABG A&B, Item Number: DYNJ43872A, Case UDI/GTIN: 40889942238942, Unit UDI/GTIN: 10889942238941, Lot Number: 22JBM586;
qqqqqq. PK, OPEN HEART-A&B, Item Number: DYNJ43895G, Case UDI/GTIN: 40193489203395, Unit UDI/GTIN: 10193489203394, Lot Number: 22JBM587,22JBJ484,22HBP784;
rrrrrr. VASCULAR PACK, Item Number: DYNJ43945I, Case UDI/GTIN: 40193489704243, Unit UDI/GTIN: 10193489704242, Lot Number: 22JMG347,22HMD283;
ssssss. PK, OPEN HEART, Item Number: DYNJ43970, Case UDI/GTIN: 40888277077165, Unit UDI/GTIN: 10888277077164, Lot Number: 22JBB067,22IBA908,22HBI904;
tttttt. PK, OPEN HEART, Item Number: DYNJ43979A, Case UDI/GTIN: 40889942010784, Unit UDI/GTIN: 10889942010783, Lot Number: 22IBV693;
uuuuuu. OPEN HEART PACK, Item Number: DYNJ44025A, Case UDI/GTIN: 40193489204668, Unit UDI/GTIN: 10193489204667, Lot Number: 22IBS470;
vvvvvv. PK, OPEN HEART-A&B, Item Number: DYNJ44026C, Case UDI/GTIN: 40193489433518, Unit UDI/GTIN: 10193489433517, Lot Number: 22IBN326,22IBN327;
wwwwww. OPEN HEART PACK, Item Number: DYNJ44033, Case UDI/GTIN: 40888277079862, Unit UDI/GTIN: 10888277079861, Lot Number: 22JBI150,22HBY546;
xxxxxx. PK, OPEN HEART-CABG, Item Number: DYNJ44067A, Case UDI/GTIN: 40193489757898, Unit UDI/GTIN: 10193489757897, Lot Number: 22JBU916;
yyyyyy. PK, OPEN HEART, Item Number: DYNJ44090D, Case UDI/GTIN: 40195327133338, Unit UDI/GTIN: 10195327133337, Lot Number: 22IBN978;
zzzzzz. CASTRO CABG-COMPONENT PACK, Item Number: DYNJ44857T, Case UDI/GTIN: 40195327221950, Unit UDI/GTIN: 10195327221959, Lot Number: 22JBD481;
aaaaaaa. RE-ENTRY PACK, Item Number: DYNJ44890F, Case UDI/GTIN: 40195327127757, Unit UDI/GTIN: 10195327127756, Lot Number: 22JDA683;
bbbbbbb. HEART PACK, Item Number: DYNJ45022B, Case UDI/GTIN: 40193489657938, Unit UDI/GTIN: 10193489657937, Lot Number: 22JBT974,22HBY537,22HBV710;
ccccccc. OPEN HEART SUPPLY PACK, Item Number: DYNJ45025A, Case UDI/GTIN: 40889942609131, Unit UDI/GTIN: 10889942609130, Lot Number: 22JLA524,22ILA816;
ddddddd. PK, OPEN HEART-CABG, Item Number: DYNJ45048C, Case UDI/GTIN: 40193489808880, Unit UDI/GTIN: 10193489808889, Lot Number: 22IMD722;
eeeeeee. CABG PROCEDURE PACK, Item Number: DYNJ45060D, Case UDI/GTIN: 40889942613633, Unit UDI/GTIN: 10889942613632, Lot Number: 22JBM611;
fffffff. CABG PACK, Item Number: DYNJ45073I, Case UDI/GTIN: 40195327044726, Unit UDI/GTIN: 10195327044725, Lot Number: 22IBO185;
ggggggg. PK, OPEN HEART, Item Number: DYNJ45074C, Case UDI/GTIN: 40193489222679, Unit UDI/GTIN: 10193489222678, Lot Number: 22IBC441,22HBW259;
hhhhhhh. VASCULAR GRAFT PACK, Item Number: DYNJ45076C, Case UDI/GTIN: 40889942947424, Unit UDI/GTIN: 10889942947423, Lot Number: 22HBI833;
iiiiiii. PK, OPEN HEART, Item Number: DYNJ45179C, Case UDI/GTIN: 40193489204217, Unit UDI/GTIN: 10193489204216, Lot Number: 22IBL978,22HBI927;
jjjjjjj. VASCULAR PACK, Item Number: DYNJ45422C, Case UDI/GTIN: 40195327040650, Unit UDI/GTIN: 10195327040659, Lot Number: 22JMF415;
kkkkkkk. PK, OPEN HEART, Item Number: DYNJ46237D, Case UDI/GTIN: 40193489322843, Unit UDI/GTIN: 10193489322842, Lot Number: 22JBW004,22IBJ774,22HBR324;
lllllll. OPEN HEART MINOR PACK, Item Number: DYNJ46425G, Case UDI/GTIN: 40193489833578, Unit UDI/GTIN: 10193489833577, Lot Number: 22JBW515,22IBT435,22IBH125,22IBH126,22IBH130;
mmmmmmm. CABG PACK(CBSJE)227-LF, Item Number: DYNJ47486A, Case UDI/GTIN: 40889942106234, Unit UDI/GTIN: 10889942106233, Lot Number: 22IBQ923;
nnnnnnn. OPEN HEART PACK (OHSJC)227, Item Number: DYNJ47493D, Case UDI/GTIN: 40889942324744, Unit UDI/GTIN: 10889942324743, Lot Number: 22IMF207,22IMF212;
ooooooo. PACEMAKER PACK, Item Number: DYNJ47619B, Case UDI/GTIN: 40193489730976, Unit UDI/GTIN: 10193489730975, Lot Number: 22JBJ759;
ppppppp. BR VASCULAR PACK, Item Number: DYNJ47628A, Case UDI/GTIN: 40888277843340, Unit UDI/GTIN: 10888277843349, Lot Number: 22JBG043;
qqqqqqq. VBMC OPEN HEART PACK, Item Number: DYNJ47638A, Case UDI/GTIN: 40193489735377, Unit UDI/GTIN: 10193489735376, Lot Number: 22JBT976,22HBX785;
rrrrrrr. PACEMAKER-LF, Item Number: DYNJ47644D, Case UDI/GTIN: 40193489952125, Unit UDI/GTIN: 10193489952124, Lot Number: 22IMH194;
sssssss. OPEN HEART PACK-RFD-LF, Item Number: DYNJ47770O, Case UDI/GTIN: 40193489308304, Unit UDI/GTIN: 10193489308303, Lot Number: 22JBB013,22IBI370;
ttttttt. PACEMAKER PACK, Item Number: DYNJ47772G, Case UDI/GTIN: 40193489463263, Unit UDI/GTIN: 10193489463262, Lot Number: 22HMD743;
uuuuuuu. VASCULAR PACK-LF, Item Number: DYNJ48196C, Case UDI/GTIN: 40193489712460, Unit UDI/GTIN: 10193489712469, Lot Number: 22HBP970;
vvvvvvv. CV VASCULAR PACK, Item Number: DYNJ48253J, Case UDI/GTIN: 40193489805735, Unit UDI/GTIN: 10193489805734, Lot Number: 22JMH939;
wwwwwww. HEART A&B PACK, Item Number: DYNJ48313F, Case UDI/GTIN: 40193489840354, Unit UDI/GTIN: 10193489840353, Lot Number: 22JBI418,22HBW107;
xxxxxxx. OPEN HEART PACK, Item Number: DYNJ49059, Case UDI/GTIN: 40888277815576, Unit UDI/GTIN: 10888277815575, Lot Number: 22HBJ896;
yyyyyyy. HAVASU BASIC OPEN HEART PACK, Item Number: DYNJ49104C, Case UDI/GTIN: 40193489776554, Unit UDI/GTIN: 10193489776553, Lot Number: 22IMC796,22HMB847;
zzzzzzz. VASCULAR PACK, Item Number: DYNJ49156, Case UDI/GTIN: 40888277819277, Unit UDI/GTIN: 10888277819276, Lot Number: 22HME394;
aaaaaaaa. PK, EP LAB, Item Number: DYNJ49513C, Case UDI/GTIN: 40193489268301, Unit UDI/GTIN: 10193489268300, Lot Number: 22JMD840,22IME354,22IME355;
bbbbbbbb. PACEMAKER PACK, Item Number: DYNJ49534A, Case UDI/GTIN: 40889942275688, Unit UDI/GTIN: 10889942275687, Lot Number: 22JBU805,22IBG083;
cccccccc. CARDIOVASCULAR PACK LJ-LF, Item Number: DYNJ49635F, Case UDI/GTIN: 40195327191406, Unit UDI/GTIN: 10195327191405, Lot Number: 22IMI321,22IMH472,22IMD161;
dddddddd. PACEMAKER PACK, Item Number: DYNJ50379A, Case UDI/GTIN: 40889942300922, Unit UDI/GTIN: 10889942300921, Lot Number: 22JBX697;
eeeeeeee. CAROTID VASCULAR ENDARTERECTMY, Item Number: DYNJ50528M, Case UDI/GTIN: 40195327129690, Unit UDI/GTIN: 10195327129699, Lot Number: 22HBX666;
ffffffff. MARQUETTE CV PACK, Item Number: DYNJ50987C, Case UDI/GTIN: 40193489499088, Unit UDI/GTIN: 10193489499087, Lot Number: 22HDB888;
gggggggg. DR DANIELSON AC PACK, Item Number: DYNJ51038Q, Case UDI/GTIN: 40195327174072, Unit UDI/GTIN: 10195327174071, Lot Number: 22JBI155;
hhhhhhhh. PACEMAKER INSERTION PACK, Item Number: DYNJ51097A, Case UDI/GTIN: 40193489985390, Unit UDI/GTIN: 10193489985399, Lot Number: 22HDC254;
iiiiiiii. MAJOR VASCULAR PACK, Item Number: DYNJ51305B, Case UDI/GTIN: 40193489460972, Unit UDI/GTIN: 10193489460971, Lot Number: 22JMG823;
jjjjjjjj. PACEMAKER PACK-LF, Item Number: DYNJ51844B, Case UDI/GTIN: 40889942615774, Unit UDI/GTIN: 10889942615773, Lot Number: 22JMA106;
kkkkkkkk. MAJOR VASCULAR PACK-LF, Item Number: DYNJ52054A, Case UDI/GTIN: 40195327104567, Unit UDI/GTIN: 10195327104566, Lot Number: 22HBL905;
llllllll. HEART PACK, Item Number: DYNJ52362G, Case UDI/GTIN: 40195327237739, Unit UDI/GTIN: 10195327237738, Lot Number: 22IBK723;
mmmmmmmm. VALVE PACK, Item Number: DYNJ52363D, Case UDI/GTIN: 40195327183807, Unit UDI/GTIN: 10195327183806, Lot Number: 22JBD487,22IBS584;
nnnnnnnn. PACEMAKER PACK, Item Number: DYNJ53636A, Case UDI/GTIN: 40193489292863, Unit UDI/GTIN: 10193489292862, Lot Number: 22IBQ560;
oooooooo. CABG PACK, Item Number: DYNJ53827, Case UDI/GTIN: 40889942444015, Unit UDI/GTIN: 10889942444014, Lot Number: 22JBD306;
pppppppp. VASCULAR PACK, Item Number: DYNJ53995G, Case UDI/GTIN: 40195327073764, Unit UDI/GTIN: 10195327073763, Lot Number: 22IBD708;
qqqqqqqq. VASCULAR PACK-LF, Item Number: DYNJ54381G, Case UDI/GTIN: 40193489815444, Unit UDI/GTIN: 10193489815443, Lot Number: 22JMH270;
rrrrrrrr. CABG INTRA OP SURGICOUNT PACK, Item Number: DYNJ55823G, Case UDI/GTIN: 40193489953498, Unit UDI/GTIN: 10193489953497, Lot Number: 22JBC268,22HBX703;
ssssssss. PK, OPEN HEART, Item Number: DYNJ56089, Case UDI/GTIN: 40889942603344, Unit UDI/GTIN: 10889942603343, Lot Number: 22IBM871,22HBW951,22HMC219;
tttttttt. PEDIATRIC OPEN HEART PACK, Item Number: DYNJ56796, Case UDI/GTIN: 40889942681458, Unit UDI/GTIN: 10889942681457, Lot Number: 22JMG835,22IMB362,22HMC357;
uuuuuuuu. PCNL PACK-LF, Item Number: DYNJ56954B, Case UDI/GTIN: 40889942778158, Unit UDI/GTIN: 10889942778157, Lot Number: 22IMG593;
vvvvvvvv. CAROTID PACK-LF, Item Number: DYNJ57646B, Case UDI/GTIN: 40193489828505, Unit UDI/GTIN: 10193489828504, Lot Number: 22IME979;
wwwwwwww. ENSEMBLE VALVE-LF, Item Number: DYNJ58123B, Case UDI/GTIN: 40195327078721, Unit UDI/GTIN: 10195327078720, Lot Number: 22IBL147,22IBK251,22HBF572;
xxxxxxxx. PONTAGE-LF, Item Number: DYNJ58124C, Case UDI/GTIN: 40195327078738, Unit UDI/GTIN: 10195327078737, Lot Number: 22HBH900;
yyyyyyyy. MINOR CARDIAC PACK-LF, Item Number: DYNJ58381C, Case UDI/GTIN: 40193489230711, Unit UDI/GTIN: 10193489230710, Lot Number: 22JMC834,22JMC835,22HMC125;
zzzzzzzz. FEMORAL A LINE PACK-LF, Item Number: DYNJ59102A, Case UDI/GTIN: 40195327040643, Unit UDI/GTIN: 10195327040642, Lot Number: 22IMD766;
aaaaaaaaa. PACEMAKER PACK, Item Number: DYNJ59123, Case UDI/GTIN: 40889942937500, Unit UDI/GTIN: 10889942937509, Lot Number: 22HLB249;
bbbbbbbbb. VASCULAR PACK, Item Number: DYNJ59361B, Case UDI/GTIN: 40195327000340, Unit UDI/GTIN: 10195327000349, Lot Number: 22JBI630,22IBM237;
ccccccccc. OPEN HEART A&B PACK, Item Number: DYNJ59604A, Case UDI/GTIN: 40193489457927, Unit UDI/GTIN: 10193489457926, Lot Number: 22JBT640,22IBK862,22HBZ301;
ddddddddd. PK, OPEN HEART, Item Number: DYNJ59695B, Case UDI/GTIN: 40193489791182, Unit UDI/GTIN: 10193489791181, Lot Number: 22JBU415,22IBJ783;
eeeeeeeee. PACEMAKER PACK, Item Number: DYNJ60055, Case UDI/GTIN: 40888277794147, Unit UDI/GTIN: 10888277794146, Lot Number: 22JBK003,22HBY483;
fffffffff. PK, OPEN HEART-FIRSTY/HANNA, Item Number: DYNJ63108A, Case UDI/GTIN: 40193489781381, Unit UDI/GTIN: 10193489781380, Lot Number: 22JMD080,22IMB793;
ggggggggg. CABG ACCESSORIES, Item Number: DYNJ63134A, Case UDI/GTIN: 40193489432597, Unit UDI/GTIN: 10193489432596, Lot Number: 22IBC805;
hhhhhhhhh. PEDS HEART MAJOR, Item Number: DYNJ63135, Case UDI/GTIN: 40193489721615, Unit UDI/GTIN: 10193489721614, Lot Number: 22IBD750;
iiiiiiiii. HEART MAJOR, Item Number: DYNJ63136B, Case UDI/GTIN: 40193489833585, Unit UDI/GTIN: 10193489833584, Lot Number: 22JBX699,22IBT444;
jjjjjjjjj. VASCULAR PACK, Item Number: DYNJ63182, Case UDI/GTIN: 40193489723404, Unit UDI/GTIN: 10193489723403, Lot Number: 22JBI165,22HBL764;
kkkkkkkkk. NOLEN VALVE PACK, Item Number: DYNJ63767B, Case UDI/GTIN: 40193489266796, Unit UDI/GTIN: 10193489266795, Lot Number: 22JBI672;
lllllllll. CV MINOR PK, Item Number: DYNJ64038, Case UDI/GTIN: 40193489782142, Unit UDI/GTIN: 10193489782141, Lot Number: 22IMI061,22HMD756;
mmmmmmmmm. HEART CABG PK, Item Number: DYNJ64040C, Case UDI/GTIN: 40195327050215, Unit UDI/GTIN: 10195327050214, Lot Number: 22IMF685;
nnnnnnnnn. NON CABG PK, Item Number: DYNJ64046B, Case UDI/GTIN: 40195327050208, Unit UDI/GTIN: 10195327050207, Lot Number: 22IMF875;
ooooooooo. CVOR ENDOVASCULAR PACK, Item Number: DYNJ64506A, Case UDI/GTIN: 40193489971065, Unit UDI/GTIN: 10193489971064, Lot Number: 22JBN274,22IBS808;
ppppppppp. VASCULAR, Item Number: DYNJ64767A, Case UDI/GTIN: 40193489456159, Unit UDI/GTIN: 10193489456158, Lot Number: 22IDA696;
qqqqqqqqq. VASCULAR SHARED, Item Number: DYNJ64801B, Case UDI/GTIN: 40195327218127, Unit UDI/GTIN: 10195327218126, Lot Number: 22JDB419,22HDC153;
rrrrrrrrr. CARDIAC PACK, Item Number: DYNJ65027B, Case UDI/GTIN: 40193489471992, Unit UDI/GTIN: 10193489471991, Lot Number: 22JBT419,22JBE649;
sssssssss. PACEMAKER PACK, Item Number: DYNJ66006, Case UDI/GTIN: 40193489312585, Unit UDI/GTIN: 10193489312584, Lot Number: 22HBP090;
ttttttttt. OPEN HEART ORANGE PARK PACK, Item Number: DYNJ66157, Case UDI/GTIN: 40193489319744, Unit UDI/GTIN: 10193489319743, Lot Number: 22JBO191;
uuuuuuuuu. VASCULAR PACK, Item Number: DYNJ66577, Case UDI/GTIN: 40193489360968, Unit UDI/GTIN: 10193489360967, Lot Number: 22IBM137;
vvvvvvvvv. VASCULAR PACK, Item Number: DYNJ66614, Case UDI/GTIN: 40193489366410, Unit UDI/GTIN: 10193489366419, Lot Number: 22IMF244;
wwwwwwwww. VASCULAR PACK, Item Number: DYNJ67151A, Case UDI/GTIN: 40195327023813, Unit UDI/GTIN: 10195327023812, Lot Number: 22JBX719,22IBJ917,22HBX262,22HBU801;
xxxxxxxxx. HEART CORE PACK, Item Number: DYNJ67157B, Case UDI/GTIN: 40195327144785, Unit UDI/GTIN: 10195327144784, Lot Number: 22IBJ818,22HBG187;
yyyyyyyyy. FEM POP PACK, Item Number: DYNJ67487C, Case UDI/GTIN: 40195327260744, Unit UDI/GTIN: 10195327260743, Lot Number: 22JMA136;
zzzzzzzzz. OPEN HEART A PACK, Item Number: DYNJ67623, Case UDI/GTIN: 40193489418836, Unit UDI/GTIN: 10193489418835, Lot Number: 22JBP733,22HBV439;
aaaaaaaaaa. TAVR PACK, Item Number: DYNJ67982, Case UDI/GTIN: 40193489462150, Unit UDI/GTIN: 10193489462159, Lot Number: 22IBO547;
bbbbbbbbbb. PACEMAKER KIT, Item Number: DYNJ68625A, Case UDI/GTIN: 40195327165797, Unit UDI/GTIN: 10195327165796, Lot Number: 22IMG706;
cccccccccc. MAJOR VASCULAR PACK, Item Number: DYNJ68843A, Case UDI/GTIN: 40195327159635, Unit UDI/GTIN: 10195327159634, Lot Number: 22JMC671;
dddddddddd. AV FISTULA PACK, Item Number: DYNJ69443C, Case UDI/GTIN: 40195327129737, Unit UDI/GTIN: 10195327129736, Lot Number: 22ILB101,22HLB068;
eeeeeeeeee. AV FISTULA PACK, Item Number: DYNJ69443D, Case UDI/GTIN: 40195327270231, Unit UDI/GTIN: 10195327270230, Lot Number: 22JLA953;
ffffffffff. ANEURSYM PACK, Item Number: DYNJ69505, Case UDI/GTIN: 40193489949880, Unit UDI/GTIN: 10193489949889, Lot Number: 22IBR836;
gggggggggg. PACEMAKER PACK-LF, Item Number: DYNJ69582, Case UDI/GTIN: 40193489953658, Unit UDI/GTIN: 10193489953657, Lot Number: 22JMI070;
hhhhhhhhhh. VASCULAR PACK, Item Number: DYNJ80310, Case UDI/GTIN: 40195327023202, Unit UDI/GTIN: 10195327023201, Lot Number: 22JLA602;
iiiiiiiiii. VASCULAR MINOR PACK, Item Number: DYNJ80482, Case UDI/GTIN: 40195327044702, Unit UDI/GTIN: 10195327044701, Lot Number: 22JLA776;
jjjjjjjjjj. DR MELLINGER AC PACK, Item Number: DYNJ80609A, Case UDI/GTIN: 40195327127832, Unit UDI/GTIN: 10195327127831, Lot Number: 22HBR311;
kkkkkkkkkk. OR INTERVENTIONAL PACK, Item Number: DYNJ81295, Case UDI/GTIN: 40195327106707, Unit UDI/GTIN: 10195327106706, Lot Number: 22IBV490;
llllllllll. CAROTID ENDARTERECTOMY, Item Number: DYNJ82025, Case UDI/GTIN: 40195327161416, Unit UDI/GTIN: 10195327161415, Lot Number: 22IMB827;
mmmmmmmmmm. PACEMAKER PACK, Item Number: DYNJ82073, Case UDI/GTIN: 40195327165483, Unit UDI/GTIN: 10195327165482, Lot Number: 22IDA710;
nnnnnnnnnn. HEART A&B PACK, Item Number: DYNJ82132, Case UDI/GTIN: 40195327175529, Unit UDI/GTIN: 10195327175528, Lot Number: 22JBH529,22HBX764;
oooooooooo. VASCULAR PACK, Item Number: DYNJ82493, Case UDI/GTIN: 40195327197491, Unit UDI/GTIN: 10195327197490, Lot Number: 22JBT984;
pppppppppp. MINOR VASCULAR PACK, Item Number: DYNJ82509, Case UDI/GTIN: 40195327198566, Unit UDI/GTIN: 10195327198565, Lot Number: 22HLA919;
qqqqqqqqqq. OPEN HEART PACK, Item Number: DYNJ82512, Case UDI/GTIN: 40195327198597, Unit UDI/GTIN: 10195327198596, Lot Number: 22JBS659,22HBX719;
rrrrrrrrrr. MAJOR VASCULAR PACK, Item Number: DYNJ82513, Case UDI/GTIN: 40195327198603, Unit UDI/GTIN: 10195327198602, Lot Number: 22KLA187,22ILA767,22HLA920;
ssssssssss. MINOR CARDIAC PACK, Item Number: DYNJ82514, Case UDI/GTIN: 40195327198610, Unit UDI/GTIN: 10195327198619, Lot Number: 22HBQ014;
tttttttttt. ENDOVASCULAR PACK, Item Number: DYNJ82516, Case UDI/GTIN: 40195327198634, Unit UDI/GTIN: 10195327198633, Lot Number: 22JLA592,22HLA946;
uuuuuuuuuu. AV GRAFT PACK, Item Number: DYNJ82519, Case UDI/GTIN: 40195327198351, Unit UDI/GTIN: 10195327198350, Lot Number: 22HBL402;
vvvvvvvvvv. VP SHUNT PK, Item Number: DYNJ82547, Case UDI/GTIN: 40195327197934, Unit UDI/GTIN: 10195327197933, Lot Number: 22HBR208;
wwwwwwwwww. PERIPHERAL VASCULAR PACK, Item Number: DYNJ82566, Case UDI/GTIN: 40195327198023, Unit UDI/GTIN: 10195327198022, Lot Number: 22HBR213;
xxxxxxxxxx. ENDO VASCULAR PACK, Item Number: DYNJ82567, Case UDI/GTIN: 40195327198030, Unit UDI/GTIN: 10195327198039, Lot Number: 22HBZ378;
yyyyyyyyyy. BASIC CARDIAC PACK, Item Number: DYNJ82569, Case UDI/GTIN: 40195327198054, Unit UDI/GTIN: 10195327198053, Lot Number: 22HBQ042;
zzzzzzzzzz. AV FISTULA CAROTID PACK, Item Number: DYNJ82570, Case UDI/GTIN: 40195327198061, Unit UDI/GTIN: 10195327198060, Lot Number: 22IBL551;
aaaaaaaaaaa. VP SHUNT PACK, Item Number: DYNJ82615, Case UDI/GTIN: 40195327199013, Unit UDI/GTIN: 10195327199012, Lot Number: 22HBH215;
bbbbbbbbbbb. VASCULAR PACK, Item Number: DYNJ82643, Case UDI/GTIN: 40195327199426, Unit UDI/GTIN: 10195327199425, Lot Number: 22KBB437,22JBN922;
ccccccccccc. PACER PACK, Item Number: DYNJ82710, Case UDI/GTIN: 40195327203611, Unit UDI/GTIN: 10195327203610, Lot Number: 22JBG048;
ddddddddddd. OPEN HEART PACK, Item Number: DYNJ82721, Case UDI/GTIN: 40195327205448, Unit UDI/GTIN: 10195327205447, Lot Number: 22JBK155;
eeeeeeeeeee. CABG PACK, Item Number: DYNJ83030, Case UDI/GTIN: 40195327229253, Unit UDI/GTIN: 10195327229252, Lot Number: 22JMH643;
fffffffffff. CABG, Item Number: DYNJ900493A, Case UDI/GTIN: 40888277577535, Unit UDI/GTIN: 10888277577534, Lot Number: 22JBW713,22IBR911;
ggggggggggg. OPEN HEART, Item Number: DYNJ901017B, Case UDI/GTIN: 40889942682943, Unit UDI/GTIN: 10889942682942, Lot Number: 22JBR407,22JBB463,22IBS650;
hhhhhhhhhhh. CAROTID-LF, Item Number: DYNJ901745K, Case UDI/GTIN: 40193489482233, Unit UDI/GTIN: 10193489482232, Lot Number: 22JDB125,22IDB949;
iiiiiiiiiii. HEART II MARYVIEW, Item Number: DYNJ902967K, Case UDI/GTIN: 40195327164899, Unit UDI/GTIN: 10195327164898, Lot Number: 22JBW828,22JBM969,22JBN226,22JBL392,22IBO242;
jjjjjjjjjjj. DR DAVIES CV, Item Number: DYNJ903016D, Case UDI/GTIN: 40195327061501, Unit UDI/GTIN: 10195327061500, Lot Number: 22KBB048;
kkkkkkkkkkk. AV GRAFT, Item Number: DYNJ903457D, Case UDI/GTIN: 40193489670913, Unit UDI/GTIN: 10193489670912, Lot Number: 22JBY045,22JBG201;
lllllllllll. CV, Item Number: DYNJ903469I, Case UDI/GTIN: 40195327175611, Unit UDI/GTIN: 10195327175610, Lot Number: 22JDB182;
mmmmmmmmmmm. CV A, Item Number: DYNJ904678F, Case UDI/GTIN: 40193489762267, Unit UDI/GTIN: 10193489762266, Lot Number: 22JDB252;
nnnnnnnnnnn. CUSTOM OPEN HEART, Item Number: DYNJ904718B, Case UDI/GTIN: 40193489493840, Unit UDI/GTIN: 10193489493849, Lot Number: 22ILA837;
ooooooooooo. VASCULAR/OR ANGIO, Item Number: DYNJ905079F, Case UDI/GTIN: 40195327209002, Unit UDI/GTIN: 10195327209001, Lot Number: 22IBS192;
ppppppppppp. ARM VASCULAR-LF, Item Number: DYNJ905290D, Case UDI/GTIN: 40195327062539, Unit UDI/GTIN: 10195327062538, Lot Number: 22HBS587;
qqqqqqqqqqq. SILVER CROSS OPEN HEART, Item Number: DYNJ906102F, Case UDI/GTIN: 40195327028269, Unit UDI/GTIN: 10195327028268, Lot Number: 22JBC452;
rrrrrrrrrrr. OPEN HEART 2 PACK-LF, Item Number: DYNJ906500B, Case UDI/GTIN: 40195327225743, Unit UDI/GTIN: 10195327225742, Lot Number: 22JBA144,22IBL683;
sssssssssss. VATS/THORACOTOMY, Item Number: DYNJ906560C, Case UDI/GTIN: 40195327171132, Unit UDI/GTIN: 10195327171131, Lot Number: 22IBF553;
ttttttttttt. VASCULAR, Item Number: DYNJ906682A, Case UDI/GTIN: 40195327225699, Unit UDI/GTIN: 10195327225698, Lot Number: 22JBA046,22JBA047;
uuuuuuuuuuu. LEWIS CV, Item Number: DYNJ906691A, Case UDI/GTIN: 40195327061525, Unit UDI/GTIN: 10195327061524, Lot Number: 22JBQ947;
vvvvvvvvvvv. AV FISTULA, Item Number: DYNJ907975A, Case UDI/GTIN: 40195327155071, Unit UDI/GTIN: 10195327155070, Lot Number: 22KLA231;
wwwwwwwwwww. ENDOVASCULAR, Item Number: DYNJ907980B, Case UDI/GTIN: 40195327204526, Unit UDI/GTIN: 10195327204525, Lot Number: 22IBS959,22IBD963,22HBU957;
xxxxxxxxxxx. FS OPEN HEART, Item Number: DYNJ908308, Case UDI/GTIN: 40195327036387, Unit UDI/GTIN: 10195327036386, Lot Number: 22JBX921,22IBS692;
yyyyyyyyyyy. CUH TAVR W/INSTRUMENTS, Item Number: DYNJ908329, Case UDI/GTIN: 40195327040094, Unit UDI/GTIN: 10195327040093, Lot Number: 22IBI013,22IBF869;
zzzzzzzzzzz. NON-PERFUSION CDS, Item Number: DYNJ908965, Case UDI/GTIN: 40195327228645, Unit UDI/GTIN: 10195327228644, Lot Number: 22JBV455;
aaaaaaaaaaaa. CABG, Item Number: DYNJ9372030G, Case UDI/GTIN: 40195327025435, Unit UDI/GTIN: 10195327025434, Lot Number: 22JBJ389,22IBT291;
bbbbbbbbbbbb. PACER PACK, Item Number: DYNJC2398J, Case UDI/GTIN: 40195327131464, Unit UDI/GTIN: 10195327131463, Lot Number: 22JBT604;
cccccccccccc. MAJOR VASCULAR PACK-LF, Item Number: DYNJC9307G, Case UDI/GTIN: 40195327033294, Unit UDI/GTIN: 10195327033293, Lot Number: 22JME515;
dddddddddddd. VASCULAR III, Item Number: DYNJS2035C, Case UDI/GTIN: 40193489214278, Unit UDI/GTIN: 10193489214277, Lot Number: 22JDB543;
eeeeeeeeeeee. OPEN HEART #1 #24924-SW, Item Number: DYNJV0237R, Case UDI/GTIN: 40195327227594, Unit UDI/GTIN: 10195327227593, Lot Number: 22HBX743;
ffffffffffff. CABG PACK, Item Number: PHS168248020A, Case UDI/GTIN: 40193489603997, Unit UDI/GTIN: 10193489603996, Lot Number: 22JBM981;
gggggggggggg. PACEMAKER PACK, Item Number: PHS185181027C, Case UDI/GTIN: 40193489499347, Unit UDI/GTIN: 10193489499346, Lot Number: 22HBG972,22HBH224;
hhhhhhhhhhhh. BASIC VASCULAR PACK-LF, Item Number: PHS825381002B, Case UDI/GTIN: 40193489636544, Unit UDI/GTIN: 10193489636543, Lot Number: 22JBL508;
iiiiiiiiiiii. VASCULAR PACK-LF, Item Number: PHS988181D, Case UDI/GTIN: 40193489766029, Unit UDI/GTIN: 10193489766028, Lot Number: 22IMB845;
|
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Karin Johnson
886-359-1704 |
|---|
Manufacturer Reason
for Recall | Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. |
|---|
FDA Determined
Cause 2 | Device Design |
|---|
| Action | Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed. |
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| Quantity in Commerce | 12,964 cases (23,379 units) |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates. |
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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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