| |
Class 2 Device Recall Sterile Procedural Trays |
 |
| Date Initiated by Firm |
November 17, 2022 |
| Date Posted |
February 06, 2023 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-1077-2023 |
| Recall Event ID |
91386 |
| Product Classification |
Plastic surgery and accessories kit - Product Code FTN
|
| Product |
Sterile Procedural Trays, labeled as the following:
a. BREAST AUGMENTATION
b. BREAST REDUCTION CDS
c. CUH ABDOMINOPLASTY CDS
d. ACH PLASTICS BREAST-LF
e. NE BREAST RECON CDS
f. PLASTIC SURGERY CDS
g. MINOR PLASTIC CDS
h. GROTH BREAST CDS
i. BREAST ABD
j. MINOR/U-BAR CDS-LF
k. PLASTIC BREAST CDS-LF
l. BREAST-HERNIA-PORT CDS-LF
m. DAY SURG PLASTIC CDS
n. PLASTIC SURGERY PACK
o. PLASTIC PACK-LF
p. PLASTIC-GENERAL SURGERY PACK
q. PLASTIC PACK-LF
r. ABDOMINOPLASTY/BREAST
s. PLASTIC PACK
t. BREAST PACK
u. PLASTIC SURGERY TRAY
v. BREAST AUGMENTATION PACK
w. FACE PACK
x. LIPOSUCTION PACK
y. UNIVERSAL PLASTIC PACK
z. PLASTIC PACK
aa. LIPOSUCTION PACK
bb. MINOR BREAST PACK
cc. PLASTICS PACK-LF
dd. UPPER PLASTIC PACK-LF
ee. BREAST MAJOR PACK-LF
ff. CAM PARTIAL MASTECTOMY PACK
gg. PLASTIC PACK
hh. BREAST PACK
ii. BREAST RECONS COMBO PK XM-LF
jj. PLASTICS PACK
kk. BREAST REDUCTION PACK
ll. BREAST HERNIA PK
mm. T PLASTY PACK
nn. ASC PLASTICS PACK
oo. PLASTICS PACK-LF
pp. OCULOPLASTIC PICK PACK
qq. PLASTIC SURGERY LF PACK
rr. PLASTIC PACK
ss. OCULAR PLASTIC PACK
tt. CHEST BREAST PACK
uu. BREAST PACK
vv. MAJOR PLASTIC PACK
ww. FACIAL PLASTICS PACK
xx. PLASTIC PACK
yy. BREAST PACK
zz. CHEST/BREAST PACK
aaa. BREAST PACK
bbb. BREAST PACK LJ-LF
ccc. SCRIPPS SW PLASTIC PACK
ddd. BREAST PACK
eee. BREAST PACK
fff. PLASTIC SURGERY U-BAR PACK
ggg. PHOENIXVILLE BREAST PACK
hhh. LAB PLASTIC PACK #DF2
iii. PLASTIC PACK
jjj. GENERAL PLASTIC PACK
kkk. CHEST/BREAST
lll. MAJOR PLASTIC PACK
mmm. MAJOR BREAST PACK
nnn. BREAST ABDOMINOPLASTY PACK
ooo. DR HOLCOMB FACIAL PACK
ppp. MAJOR PLASTIC BREAST PACK
qqq. DIAZ PACK
rrr. BREAST PACK
sss. BREAST PACK
ttt. CHEST PACK
uuu. PLASTIC FACIAL PACK
vvv. FACIAL PLASTICS PACK
www. BLEPHAROPLASTY PACK
xxx. BREAST PACK - MOISES
yyy. PLASTIC PACK
zzz. PLASTIC PACK
aaaa. BREAST AUGMENTATION PACK
bbbb. CHEST/BREAST
cccc. BREAST PACK
dddd. PLASTIC PACK
eeee. PLASTICS PACK
ffff. PLASTIC PACK
gggg. CHEST BREAST PACK
hhhh. PLASTIC PACK
iiii. CAROLINA FACIAL PLASTIC PACK
jjjj. BREAST PACK
kkkk. CHEST BREAST PACK
llll. BREAST DBL PROCED SUPPLEMENT
mmmm. BREAST PACK
nnnn. PLASTIC PACK
oooo. PLASTICS PACK
pppp. ESC PLASTICS PACK
qqqq. FACE LIFT PACK
rrrr. CHEST BREAST
ssss. BREAST PACK
tttt. MINOR PLASTIC PACK
uuuu. #2 FACIAL PLASTY PACK
vvvv. BBL PACK
wwww. BASIC PACK
xxxx. BREAST PACK
yyyy. BREAST AUGMENTATION PACK
zzzz. BREAST PACK
aaaaa. MAJOR BREAST OR UNIVERSAL
bbbbb. CHEST/BREAST-LF
ccccc. CUSTOM PLASTIC PACK
ddddd. CHEST/BREAST PACK
eeeee. PLASTIC GENERAL PACK
fffff. SPECIALTY FACIAL PLASTICS PACK
ggggg. OCCULOPLASTICS PACK
hhhhh. BREAST PACK
iiiii. LIPOSUCTION PACK
jjjjj. BREAST PACK
kkkkk. PLASTICS PACK
lllll. BREAST PACK
mmmmm. BREAST REDUCTION PACK
nnnnn. BREAST AUGMENTATION PACK
ooooo. FACE/RHINOPLASTY PACK
ppppp. BREAST PACK
qqqqq. TUMMY TUCK PACK
rrrrr. BREAST PACK
sssss. PLASTICS PACK
ttttt. BREAST/ABDOMINAL PACK
uuuuu. PLASTIC PACK
vvvvv. BREAST PACK
wwwww. RECONSTRUCTION PACK
xxxxx. PLASTIC PACK
yyyyy. PLASTICS PACK
zzzzz. PLASTICS PACK
aaaaaa. GENERAL PLASTIC-LF
bbbbbb. PLASTIC UNIVERSAL
cccccc. BREAST HA-LF
dddddd. BREAST
eeeeee. PLASTIC
ffffff. BREAST
gggggg. MAJOR BREAST
hhhhhh. CHEST/BREAST-MRMCASU
iiiiii. BREAST RECONSTRUCTION PACK
jjjjjj. CHEST/BREAST
kkkkkk. BREAST PACK
llllll. BREAST BIOPSY/MASTECTOMY
mmmmmm. CHEST/BREAST-LF |
| Code Information |
a. BREAST AUGMENTATION, Item Number: CDS982254L, Case UDI/GTIN: 40195327084791, Unit UDI/GTIN: 10195327084790, Lot Number: 22JBU069,22IBN271;
b. BREAST REDUCTION CDS, Item Number: CDS982255I, Case UDI/GTIN: 40195327084807, Unit UDI/GTIN: 10195327084806, Lot Number: 22JBB306;
c. CUH ABDOMINOPLASTY CDS, Item Number: CDS983176I, Case UDI/GTIN: 40193489767477, Unit UDI/GTIN: 10193489767476, Lot Number: 22JBJ560,22JBD705;
d. ACH PLASTICS BREAST-LF, Item Number: CDS983639J, Case UDI/GTIN: 40195327228140, Unit UDI/GTIN: 10195327228149, Lot Number: 22IBF012,22IBF004;
e. NE BREAST RECON CDS, Item Number: CDS983660G, Case UDI/GTIN: 40193489952675, Unit UDI/GTIN: 10193489952674, Lot Number: 22IBR079;
f. PLASTIC SURGERY CDS, Item Number: CDS983880C, Case UDI/GTIN: 40193489435963, Unit UDI/GTIN: 10193489435962, Lot Number: 22JBT961;
g. MINOR PLASTIC CDS, Item Number: CDS984174F, Case UDI/GTIN: 40195327084777, Unit UDI/GTIN: 10195327084776, Lot Number: 22JBM928,22JBM929;
h. GROTH BREAST CDS, Item Number: CDS984202U, Case UDI/GTIN: 40195327146307, Unit UDI/GTIN: 10195327146306, Lot Number: 22JBA856,22IBC582,22IBD063;
i. BREAST ABD, Item Number: CDS984267J, Case UDI/GTIN: 40193489288873, Unit UDI/GTIN: 10193489288872, Lot Number: 22IBF074;
j. MINOR/U-BAR CDS-LF, Item Number: CDS984539J, Case UDI/GTIN: 40193489903189, Unit UDI/GTIN: 10193489903188, Lot Number: 22JDB904;
k. PLASTIC BREAST CDS-LF, Item Number: CDS984851K, Case UDI/GTIN: 40195327195398, Unit UDI/GTIN: 10195327195397, Lot Number: 22JDB505;
l. BREAST-HERNIA-PORT CDS-LF, Item Number: CDS984853I, Case UDI/GTIN: 40195327071760, Unit UDI/GTIN: 10195327071769, Lot Number: 22JDA801;
m. DAY SURG PLASTIC CDS, Item Number: CDS984993O, Case UDI/GTIN: 40195327175765, Unit UDI/GTIN: 10195327175764, Lot Number: 22JBJ441,22JBE422;
n. PLASTIC SURGERY PACK, Item Number: DYNJ04750G, Case UDI/GTIN: 40193489511957, Unit UDI/GTIN: 10193489511956, Lot Number: 22JMB163;
o. PLASTIC PACK-LF, Item Number: DYNJ0781642R, Case UDI/GTIN: 40193489919173, Unit UDI/GTIN: 10193489919172, Lot Number: 22JMF191,22HMD493;
p. PLASTIC-GENERAL SURGERY PACK, Item Number: DYNJ09866U, Case UDI/GTIN: 40193489259590, Unit UDI/GTIN: 10193489259599, Lot Number: 22JMG311;
q. PLASTIC PACK-LF, Item Number: DYNJ20497K, Case UDI/GTIN: 40195327024599, Unit UDI/GTIN: 10195327024598, Lot Number: 22JLB117,22ILA021;
r. ABDOMINOPLASTY/BREAST, Item Number: DYNJ21842I, Case UDI/GTIN: 40888277256508, Unit UDI/GTIN: 10888277256507, Lot Number: 22IMH619;
s. PLASTIC PACK, Item Number: DYNJ26438G, Case UDI/GTIN: 40888277785350, Unit UDI/GTIN: 10888277785359, Lot Number: 22JBI434,22HBZ290;
t. BREAST PACK, Item Number: DYNJ28206K, Case UDI/GTIN: 40195327106943, Unit UDI/GTIN: 10195327106942, Lot Number: 22JBU625;
u. PLASTIC SURGERY TRAY, Item Number: DYNJ30115G, Case UDI/GTIN: 40889942303862, Unit UDI/GTIN: 10889942303861, Lot Number: 22HBV982;
v. BREAST AUGMENTATION PACK, Item Number: DYNJ33977L, Case UDI/GTIN: 40193489859936, Unit UDI/GTIN: 10193489859935, Lot Number: 22JBO157;
w. FACE PACK, Item Number: DYNJ34217A, Case UDI/GTIN: 40888277093097, Unit UDI/GTIN: 10888277093096, Lot Number: 22KBA576;
x. LIPOSUCTION PACK, Item Number: DYNJ34219B, Case UDI/GTIN: 40889942274834, Unit UDI/GTIN: 10889942274833, Lot Number: 22JBE559;
y. UNIVERSAL PLASTIC PACK, Item Number: DYNJ34914B, Case UDI/GTIN: 40888277866486, Unit UDI/GTIN: 10888277866485, Lot Number: 22IBG525;
z. PLASTIC PACK, Item Number: DYNJ35262A, Case UDI/GTIN: 40193489903431, Unit UDI/GTIN: 10193489903430, Lot Number: 22HBW347;
aa. LIPOSUCTION PACK, Item Number: DYNJ35551A, Case UDI/GTIN: 40195327097876, Unit UDI/GTIN: 10195327097875, Lot Number: 22JBK100,22IBJ806;
bb. MINOR BREAST PACK, Item Number: DYNJ35553C, Case UDI/GTIN: 40195327097852, Unit UDI/GTIN: 10195327097851, Lot Number: 22HBY241;
cc. PLASTICS PACK-LF, Item Number: DYNJ36107J, Case UDI/GTIN: 40195327080274, Unit UDI/GTIN: 10195327080273, Lot Number: 22JME255;
dd. UPPER PLASTIC PACK-LF, Item Number: DYNJ36718D, Case UDI/GTIN: 40195327148769, Unit UDI/GTIN: 10195327148768, Lot Number: 22JBL537,22IBG025;
ee. BREAST MAJOR PACK-LF, Item Number: DYNJ36734G, Case UDI/GTIN: 40195327147410, Unit UDI/GTIN: 10195327147419, Lot Number: 22HBQ666;
ff. CAM PARTIAL MASTECTOMY PACK, Item Number: DYNJ37628C, Case UDI/GTIN: 40889942461050, Unit UDI/GTIN: 10889942461059, Lot Number: 22IBU399;
gg. PLASTIC PACK, Item Number: DYNJ38189D, Case UDI/GTIN: 40193489468343, Unit UDI/GTIN: 10193489468342, Lot Number: 22IBO436;
hh. BREAST PACK, Item Number: DYNJ39195F, Case UDI/GTIN: 40193489986908, Unit UDI/GTIN: 10193489986907, Lot Number: 22IBO383;
ii. BREAST RECONS COMBO PK XM-LF, Item Number: DYNJ39833C, Case UDI/GTIN: 40195327191376, Unit UDI/GTIN: 10195327191375, Lot Number: 22FMI348;
jj. PLASTICS PACK, Item Number: DYNJ40140G, Case UDI/GTIN: 40193489265867, Unit UDI/GTIN: 10193489265866, Lot Number: 22IBH452;
kk. BREAST REDUCTION PACK, Item Number: DYNJ41002, Case UDI/GTIN: 40884389895413, Unit UDI/GTIN: 10884389895412, Lot Number: 22IBS571;
ll. BREAST HERNIA PK, Item Number: DYNJ41083D, Case UDI/GTIN: 40889942233459, Unit UDI/GTIN: 10889942233458, Lot Number: 22JBF548;
mm. T PLASTY PACK, Item Number: DYNJ41985C, Case UDI/GTIN: 40193489258173, Unit UDI/GTIN: 10193489258172, Lot Number: 22JDC078,22IDA602;
nn. ASC PLASTICS PACK, Item Number: DYNJ42011C, Case UDI/GTIN: 40888277938299, Unit UDI/GTIN: 10888277938298, Lot Number: 22JBG927,22IBB058;
oo. PLASTICS PACK-LF, Item Number: DYNJ43418C, Case UDI/GTIN: 40193489450867, Unit UDI/GTIN: 10193489450866, Lot Number: 22IBP842;
pp. OCULOPLASTIC PICK PACK, Item Number: DYNJ43914B, Case UDI/GTIN: 40889942437079, Unit UDI/GTIN: 10889942437078, Lot Number: 22JBE764;
qq. PLASTIC SURGERY LF PACK, Item Number: DYNJ43942, Case UDI/GTIN: 40888277075468, Unit UDI/GTIN: 10888277075467, Lot Number: 22HBX782,22HBX206;
rr. PLASTIC PACK, Item Number: DYNJ44099A, Case UDI/GTIN: 40889942490142, Unit UDI/GTIN: 10889942490141, Lot Number: 22JMH703,22JMA840,22HMF001;
ss. OCULAR PLASTIC PACK, Item Number: DYNJ45041B, Case UDI/GTIN: 40888277807434, Unit UDI/GTIN: 10888277807433, Lot Number: 22JBE786;
tt. CHEST BREAST PACK, Item Number: DYNJ46084, Case UDI/GTIN: 40888277221001, Unit UDI/GTIN: 10888277221000, Lot Number: 22HLB316;
uu. BREAST PACK, Item Number: DYNJ46229, Case UDI/GTIN: 40888277228345, Unit UDI/GTIN: 10888277228344, Lot Number: 22JBW530,22IBT433;
vv. MAJOR PLASTIC PACK, Item Number: DYNJ46515K, Case UDI/GTIN: 40195327008216, Unit UDI/GTIN: 10195327008215, Lot Number: 22IDA743,22IDA715,22HDB738;
ww. FACIAL PLASTICS PACK, Item Number: DYNJ46537J, Case UDI/GTIN: 40193489991520, Unit UDI/GTIN: 10193489991529, Lot Number: 22IBM221;
xx. PLASTIC PACK, Item Number: DYNJ47294, Case UDI/GTIN: 40888277298362, Unit UDI/GTIN: 10888277298361, Lot Number: 22JBV790,22HBO967;
yy. BREAST PACK, Item Number: DYNJ48160B, Case UDI/GTIN: 40888277877611, Unit UDI/GTIN: 10888277877610, Lot Number: 22HBR197,22HBL573;
zz. CHEST/BREAST PACK, Item Number: DYNJ48606, Case UDI/GTIN: 40888277915399, Unit UDI/GTIN: 10888277915398, Lot Number: 22IBO455;
aaa. BREAST PACK, Item Number: DYNJ48646B, Case UDI/GTIN: 40195327225071, Unit UDI/GTIN: 10195327225070, Lot Number: 22JMG350;
bbb. BREAST PACK LJ-LF, Item Number: DYNJ49642B, Case UDI/GTIN: 40195327191390, Unit UDI/GTIN: 10195327191399, Lot Number: 22HMG224;
ccc. SCRIPPS SW PLASTIC PACK, Item Number: DYNJ49652C, Case UDI/GTIN: 40195327191338, Unit UDI/GTIN: 10195327191337, Lot Number: 22JME793,22HMI024,22HMH476;
ddd. BREAST PACK, Item Number: DYNJ50369A, Case UDI/GTIN: 40889942442035, Unit UDI/GTIN: 10889942442034, Lot Number: 22IBH202;
eee. BREAST PACK, Item Number: DYNJ50562A, Case UDI/GTIN: 40889942716525, Unit UDI/GTIN: 10889942716524, Lot Number: 22JBW809,22JBK542,22IBB103;
fff. PLASTIC SURGERY U-BAR PACK, Item Number: DYNJ50810D, Case UDI/GTIN: 40889942675242, Unit UDI/GTIN: 10889942675241, Lot Number: 22JBW438,22HBV062;
ggg. PHOENIXVILLE BREAST PACK, Item Number: DYNJ51358B, Case UDI/GTIN: 40193489745208, Unit UDI/GTIN: 10193489745207, Lot Number: 22IBP954,22HBH541;
hhh. LAB PLASTIC PACK #DF2, Item Number: DYNJ51648B, Case UDI/GTIN: 40888277783776, Unit UDI/GTIN: 10888277783775, Lot Number: 22JBP932;
iii. PLASTIC PACK, Item Number: DYNJ51833A, Case UDI/GTIN: 40888277777256, Unit UDI/GTIN: 10888277777255, Lot Number: 22IBU484,22HBS916;
jjj. GENERAL PLASTIC PACK, Item Number: DYNJ52004F, Case UDI/GTIN: 40193489926744, Unit UDI/GTIN: 10193489926743, Lot Number: 22JBW381,22JBI156,22HBO273;
kkk. CHEST/BREAST, Item Number: DYNJ52495A, Case UDI/GTIN: 40195327132065, Unit UDI/GTIN: 10195327132064, Lot Number: 22JBV763,22IBJ865;
lll. MAJOR PLASTIC PACK, Item Number: DYNJ52759F, Case UDI/GTIN: 40193489929486, Unit UDI/GTIN: 10193489929485, Lot Number: 22JBW704;
mmm. MAJOR BREAST PACK, Item Number: DYNJ52781C, Case UDI/GTIN: 40193489568630, Unit UDI/GTIN: 10193489568639, Lot Number: 22IBN257;
nnn. BREAST ABDOMINOPLASTY PACK, Item Number: DYNJ54092G, Case UDI/GTIN: 40195327250868, Unit UDI/GTIN: 10195327250867, Lot Number: 22JME425;
ooo. DR HOLCOMB FACIAL PACK, Item Number: DYNJ54488A, Case UDI/GTIN: 40193489587860, Unit UDI/GTIN: 10193489587869, Lot Number: 22JBW776;
ppp. MAJOR PLASTIC BREAST PACK, Item Number: DYNJ54833B, Case UDI/GTIN: 40195327133727, Unit UDI/GTIN: 10195327133726, Lot Number: 22JME810;
qqq. DIAZ PACK, Item Number: DYNJ55107F, Case UDI/GTIN: 40195327085651, Unit UDI/GTIN: 10195327085650, Lot Number: 22IBO652;
rrr. BREAST PACK, Item Number: DYNJ55710A, Case UDI/GTIN: 40193489937337, Unit UDI/GTIN: 10193489937336, Lot Number: 22IMD755;
sss. BREAST PACK, Item Number: DYNJ56344B, Case UDI/GTIN: 40889942612322, Unit UDI/GTIN: 10889942612321, Lot Number: 22ILA563,22ILA180;
ttt. CHEST PACK, Item Number: DYNJ56368, Case UDI/GTIN: 40889942638179, Unit UDI/GTIN: 10889942638178, Lot Number: 22JDA291,22IDB838;
uuu. PLASTIC FACIAL PACK, Item Number: DYNJ56404B, Case UDI/GTIN: 40195327124633, Unit UDI/GTIN: 10195327124632, Lot Number: 22IBL239;
vvv. FACIAL PLASTICS PACK, Item Number: DYNJ56768A, Case UDI/GTIN: 40193489648479, Unit UDI/GTIN: 10193489648478, Lot Number: 22HBH151;
www. BLEPHAROPLASTY PACK, Item Number: DYNJ56859C, Case UDI/GTIN: 40193489224925, Unit UDI/GTIN: 10193489224924, Lot Number: 22IMI006;
xxx. BREAST PACK - MOISES, Item Number: DYNJ57118A, Case UDI/GTIN: 40193489623667, Unit UDI/GTIN: 10193489623666, Lot Number: 22HBY162;
yyy. PLASTIC PACK, Item Number: DYNJ57895, Case UDI/GTIN: 40889942790372, Unit UDI/GTIN: 10889942790371, Lot Number: 22JBN175;
zzz. PLASTIC PACK, Item Number: DYNJ59445B, Case UDI/GTIN: 40193489220071, Unit UDI/GTIN: 10193489220070, Lot Number: 22IBP590;
aaaa. BREAST AUGMENTATION PACK, Item Number: DYNJ59455B, Case UDI/GTIN: 40193489362078, Unit UDI/GTIN: 10193489362077, Lot Number: 22JBF745;
bbbb. CHEST/BREAST, Item Number: DYNJ59712B, Case UDI/GTIN: 40193489849357, Unit UDI/GTIN: 10193489849356, Lot Number: 22JBX989,22IBA042;
cccc. BREAST PACK, Item Number: DYNJ60026, Case UDI/GTIN: 40888277792402, Unit UDI/GTIN: 10888277792401, Lot Number: 22JBS904;
dddd. PLASTIC PACK, Item Number: DYNJ61755B, Case UDI/GTIN: 40195327149551, Unit UDI/GTIN: 10195327149550, Lot Number: 22JMD332,22HMF130;
eeee. PLASTICS PACK, Item Number: DYNJ61790B, Case UDI/GTIN: 40193489316125, Unit UDI/GTIN: 10193489316124, Lot Number: 22JBN158,22IBA388,22HBL885;
ffff. PLASTIC PACK, Item Number: DYNJ62042, Case UDI/GTIN: 40193489619257, Unit UDI/GTIN: 10193489619256, Lot Number: 22JME417;
gggg. CHEST BREAST PACK, Item Number: DYNJ62098C, Case UDI/GTIN: 40193489480017, Unit UDI/GTIN: 10193489480016, Lot Number: 22HME923;
hhhh. PLASTIC PACK, Item Number: DYNJ63117, Case UDI/GTIN: 40193489713801, Unit UDI/GTIN: 10193489713800, Lot Number: 22JBP063,22IBJ716;
iiii. CAROLINA FACIAL PLASTIC PACK, Item Number: DYNJ63180, Case UDI/GTIN: 40193489723060, Unit UDI/GTIN: 10193489723069, Lot Number: 22JBL015;
jjjj. BREAST PACK, Item Number: DYNJ63217, Case UDI/GTIN: 40193489729123, Unit UDI/GTIN: 10193489729122, Lot Number: 22IBA404;
kkkk. CHEST BREAST PACK, Item Number: DYNJ63290B, Case UDI/GTIN: 40195327196272, Unit UDI/GTIN: 10195327196271, Lot Number: 22HBK714;
llll. BREAST DBL PROCED SUPPLEMENT, Item Number: DYNJ63893, Case UDI/GTIN: 40193489771566, Unit UDI/GTIN: 10193489771565, Lot Number: 22JBI166;
mmmm. BREAST PACK, Item Number: DYNJ64179, Case UDI/GTIN: 40193489792653, Unit UDI/GTIN: 10193489792652, Lot Number: 22JBP470,22JBB019,22IBG074,22HBP241;
nnnn. PLASTIC PACK, Item Number: DYNJ64308B, Case UDI/GTIN: 40195327125029, Unit UDI/GTIN: 10195327125028, Lot Number: 22GDA095,22CDB784;
oooo. PLASTICS PACK, Item Number: DYNJ64418, Case UDI/GTIN: 40193489813068, Unit UDI/GTIN: 10193489813067, Lot Number: 22JBI248;
pppp. ESC PLASTICS PACK, Item Number: DYNJ64635B, Case UDI/GTIN: 40195327045754, Unit UDI/GTIN: 10195327045753, Lot Number: 22IBR794;
qqqq. FACE LIFT PACK, Item Number: DYNJ64670B, Case UDI/GTIN: 40193489484404, Unit UDI/GTIN: 10193489484403, Lot Number: 22IBA242,22HBM677;
rrrr. CHEST BREAST, Item Number: DYNJ64736A, Case UDI/GTIN: 40193489456012, Unit UDI/GTIN: 10193489456011, Lot Number: 22JDA326;
ssss. BREAST PACK, Item Number: DYNJ64810A, Case UDI/GTIN: 40193489904988, Unit UDI/GTIN: 10193489904987, Lot Number: 22JMA873;
tttt. MINOR PLASTIC PACK, Item Number: DYNJ64947, Case UDI/GTIN: 40193489233613, Unit UDI/GTIN: 10193489233612, Lot Number: 22HLA405;
uuuu. #2 FACIAL PLASTY PACK, Item Number: DYNJ64963, Case UDI/GTIN: 40193489234894, Unit UDI/GTIN: 10193489234893, Lot Number: 22IBB122;
vvvv. BBL PACK, Item Number: DYNJ65169D, Case UDI/GTIN: 40193489963114, Unit UDI/GTIN: 10193489963113, Lot Number: 22IBI908,22HBP707;
wwww. BASIC PACK, Item Number: DYNJ65328A, Case UDI/GTIN: 40193489954853, Unit UDI/GTIN: 10193489954852, Lot Number: 22JBC639;
xxxx. BREAST PACK, Item Number: DYNJ65333A, Case UDI/GTIN: 40193489954860, Unit UDI/GTIN: 10193489954869, Lot Number: 22JMA988;
yyyy. BREAST AUGMENTATION PACK, Item Number: DYNJ66015, Case UDI/GTIN: 40193489314947, Unit UDI/GTIN: 10193489314946, Lot Number: 22KLA065,22HLA980;
zzzz. BREAST PACK, Item Number: DYNJ66673B, Case UDI/GTIN: 40193489898362, Unit UDI/GTIN: 10193489898361, Lot Number: 22JBK545;
aaaaa. MAJOR BREAST OR UNIVERSAL, Item Number: DYNJ67498A, Case UDI/GTIN: 40195327039685, Unit UDI/GTIN: 10195327039684, Lot Number: 22HBS121;
bbbbb. CHEST/BREAST-LF, Item Number: DYNJ67852B, Case UDI/GTIN: 40195327177516, Unit UDI/GTIN: 10195327177515, Lot Number: 22HBW474;
ccccc. CUSTOM PLASTIC PACK, Item Number: DYNJ68062, Case UDI/GTIN: 40193489474580, Unit UDI/GTIN: 10193489474589, Lot Number: 22JBL801;
ddddd. CHEST/BREAST PACK, Item Number: DYNJ68337, Case UDI/GTIN: 40193489437479, Unit UDI/GTIN: 10193489437478, Lot Number: 22JBF706;
eeeee. PLASTIC GENERAL PACK, Item Number: DYNJ68467, Case UDI/GTIN: 40193489464581, Unit UDI/GTIN: 10193489464580, Lot Number: 22IBK005;
fffff. SPECIALTY FACIAL PLASTICS PACK, Item Number: DYNJ68844A, Case UDI/GTIN: 40195327216505, Unit UDI/GTIN: 10195327216504, Lot Number: 22HMF458;
ggggg. OCCULOPLASTICS PACK, Item Number: DYNJ69084B, Case UDI/GTIN: 40195327110353, Unit UDI/GTIN: 10195327110352, Lot Number: 22JBM523;
hhhhh. BREAST PACK, Item Number: DYNJ69319, Case UDI/GTIN: 40193489931120, Unit UDI/GTIN: 10193489931129, Lot Number: 22JBW897,22JBJ494;
iiiii. LIPOSUCTION PACK, Item Number: DYNJ69484A, Case UDI/GTIN: 40195327001996, Unit UDI/GTIN: 10195327001995, Lot Number: 22IBO417;
jjjjj. BREAST PACK, Item Number: DYNJ69656A, Case UDI/GTIN: 40195327179770, Unit UDI/GTIN: 10195327179779, Lot Number: 22HMD690;
kkkkk. PLASTICS PACK, Item Number: DYNJ80020, Case UDI/GTIN: 40195327006427, Unit UDI/GTIN: 10195327006426, Lot Number: 22HBW524;
lllll. BREAST PACK, Item Number: DYNJ80116, Case UDI/GTIN: 40195327008834, Unit UDI/GTIN: 10195327008833, Lot Number: 22HBM836;
mmmmm. BREAST REDUCTION PACK, Item Number: DYNJ80336B, Case UDI/GTIN: 40195327163342, Unit UDI/GTIN: 10195327163341, Lot Number: 22IBK852;
nnnnn. BREAST AUGMENTATION PACK, Item Number: DYNJ80337A, Case UDI/GTIN: 40195327106424, Unit UDI/GTIN: 10195327106423, Lot Number: 22CBG865;
ooooo. FACE/RHINOPLASTY PACK, Item Number: DYNJ80343B, Case UDI/GTIN: 40195327134892, Unit UDI/GTIN: 10195327134891, Lot Number: 22IBA953;
ppppp. BREAST PACK, Item Number: DYNJ80344B, Case UDI/GTIN: 40195327134908, Unit UDI/GTIN: 10195327134907, Lot Number: 22IBL114,22IBA954;
qqqqq. TUMMY TUCK PACK, Item Number: DYNJ80723, Case UDI/GTIN: 40195327070930, Unit UDI/GTIN: 10195327070939, Lot Number: 22JMA679;
rrrrr. BREAST PACK, Item Number: DYNJ81403, Case UDI/GTIN: 40195327116751, Unit UDI/GTIN: 10195327116750, Lot Number: 22IBJ907,22GBM174,22EBF641;
sssss. PLASTICS PACK, Item Number: DYNJ81692, Case UDI/GTIN: 40195327135233, Unit UDI/GTIN: 10195327135232, Lot Number: 22IBR325;
ttttt. BREAST/ABDOMINAL PACK, Item Number: DYNJ81978, Case UDI/GTIN: 40195327158621, Unit UDI/GTIN: 10195327158620, Lot Number: 22GBX424;
uuuuu. PLASTIC PACK, Item Number: DYNJ82495, Case UDI/GTIN: 40195327197514, Unit UDI/GTIN: 10195327197513, Lot Number: 22HBJ950;
vvvvv. BREAST PACK, Item Number: DYNJ82522, Case UDI/GTIN: 40195327198382, Unit UDI/GTIN: 10195327198381, Lot Number: 22HBL506;
wwwww. RECONSTRUCTION PACK, Item Number: DYNJ82532, Case UDI/GTIN: 40195327198481, Unit UDI/GTIN: 10195327198480, Lot Number: 22HBR206;
xxxxx. PLASTIC PACK, Item Number: DYNJ82571, Case UDI/GTIN: 40195327198078, Unit UDI/GTIN: 10195327198077, Lot Number: 22HBP287;
yyyyy. PLASTICS PACK, Item Number: DYNJ82648, Case UDI/GTIN: 40195327199471, Unit UDI/GTIN: 10195327199470, Lot Number: 22HBL972,22HBH559;
zzzzz. PLASTICS PACK, Item Number: DYNJ83112, Case UDI/GTIN: 40195327233298, Unit UDI/GTIN: 10195327233297, Lot Number: 22HBP990;
aaaaaa. GENERAL PLASTIC-LF, Item Number: DYNJ901738M, Case UDI/GTIN: 40195327153121, Unit UDI/GTIN: 10195327153120, Lot Number: 22IDB808;
bbbbbb. PLASTIC UNIVERSAL, Item Number: DYNJ901792I, Case UDI/GTIN: 40193489716505, Unit UDI/GTIN: 10193489716504, Lot Number: 22IBD811,22IBD810;
cccccc. BREAST HA-LF, Item Number: DYNJ902790C, Case UDI/GTIN: 40193489438483, Unit UDI/GTIN: 10193489438482, Lot Number: 22JBO945,22JBN993;
dddddd. BREAST, Item Number: DYNJ902829A, Case UDI/GTIN: 40193489640831, Unit UDI/GTIN: 10193489640830, Lot Number: 22JBH277;
eeeeee. PLASTIC, Item Number: DYNJ903330N, Case UDI/GTIN: 40195327236503, Unit UDI/GTIN: 10195327236502, Lot Number: 22KBC314,22JBR445,22JBA441;
ffffff. BREAST, Item Number: DYNJ904598B, Case UDI/GTIN: 40889942946359, Unit UDI/GTIN: 10889942946358, Lot Number: 22KBC968,22KBC969;
gggggg. MAJOR BREAST, Item Number: DYNJ905004B, Case UDI/GTIN: 40193489782586, Unit UDI/GTIN: 10193489782585, Lot Number: 22IBC407,22IBA668,22IBA065;
hhhhhh. CHEST/BREAST-MRMCASU, Item Number: DYNJ907744C, Case UDI/GTIN: 40195327181032, Unit UDI/GTIN: 10195327181031, Lot Number: 22JBP014;
iiiiii. BREAST RECONSTRUCTION PACK, Item Number: DYNJ907791B, Case UDI/GTIN: 40195327185238, Unit UDI/GTIN: 10195327185237, Lot Number: 22KBE789,22KBB846;
jjjjjj. CHEST/BREAST, Item Number: DYNJ908433B, Case UDI/GTIN: 40195327255962, Unit UDI/GTIN: 10195327255961, Lot Number: 22JBL359,22JBM145;
kkkkkk. BREAST PACK, Item Number: DYNJ908729, Case UDI/GTIN: 40195327159222, Unit UDI/GTIN: 10195327159221, Lot Number: 22JBH434;
llllll. BREAST BIOPSY/MASTECTOMY, Item Number: DYNJ908839, Case UDI/GTIN: 40195327184439, Unit UDI/GTIN: 10195327184438, Lot Number: 22HBT534;
mmmmmm. CHEST/BREAST-LF, Item Number: DYNJS0201, Case UDI/GTIN: 40080196813095, Unit UDI/GTIN: 10080196813094, Lot Number: 22IBU891,22HBX417 |
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. |
| Quantity in Commerce |
6,420 cases (15,009 units) |
| Distribution |
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates. |
| 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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