| | Class 2 Device Recall |  |
| Date Initiated by Firm | November 17, 2022 |
|---|
| Date Posted | February 06, 2023 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1072-2023 |
|---|
| Recall Event ID |
91386 |
| Product Classification |
Ear, nose, and throat surgical tray - Product Code OGR
|
| Product | Sterile Procedural Trays, labeled as the following:
a. EAR CDS-LF
b. SINUS CDS-1
c. ZALE FESS CDS
d. ZALE OTOLOGY CDS
e. ZALE HEAD & NECK CDS
f. CUH PARA/THYROIDECTOMY CDS
g. CAM ENDOSCOPIC SINUS/SEPTO CDS
h. HEAD AND NECK CDS
i. HEAD AND NECK CDS-LF
j. NASAL
k. ENT SET UP CDS
l. MINOR ENT SINUS PACK-LF
m. MAJOR EAR PACK-LF
n. THORACOTOMY HARPER PACK-LF
o. FESS NSR PACK-LF
p. ENT BASIC PACK-LF
q. HEAD & NECK-LF
r. ENT PACK-LF
s. SINOSCOPY-LF
t. MAJOR HEAD/NECK PACK-LF
u. NECK PACK
v. HEAD & NECK PACK
w. HEAD & NECK TRAY
x. ENT LAW PACK-LF
y. ENT PACK
z. NECK PACK
aa. NASAL PACK
bb. ENT PACK
cc. FREE FLAP PACK-LF
dd. TYMPANO MASTOID
ee. MINOR HEAD & NECK #40-RF
ff. EAR PACK
gg. E.N.T. TRAY
hh. EAR PACK-LF
ii. BASIC ENT PACK-LF
jj. PLASTIC HEAD & NECK PACK
kk. EAR TRAY #10-RF
ll. HEAD & NECK ENT PACK-RF-LF
mm. ENT PACK
nn. ENT PACK-LF
oo. NASAL/SEPTO PACK
pp. OSC FACE LIFT PK
qq. RRMC NASAL PACK
rr. ENT PACK
ss. HENRYS ENT PACK
tt. ENT
uu. FACE AND NASAL PACK
vv. NASAL PACK
ww. ENT PACK
xx. SINUS ENDOSCOPY-LF
yy. OSC NASAL-NOSE PACK-LF
zz. ENT PACK
aaa. FES PACK - LF
bbb. HEAD AND NECK PACK
ccc. SCRIPPS SW ENT PACK
ddd. SCRIPPS SW EAR PACK-LF
eee. HL ENT PACK
fff. CAROTID ENDARTECTOMY PK
ggg. EAR PACK
hhh. ENT FREE FLAP
iii. HEAD AND NECK PACK
jjj. TRACH PACK
kkk. HL EAR PACK
lll. NASAL SINUS ENDO PK
mmm. ENT PACK
nnn. HEAD AND NECK PACK
ooo. ENT PACK
ppp. HEAD AND NECK PACK
qqq. ASC HEAD & NECK PACK
rrr. ENT PACK
sss. DEACONESS HEAD AND NECK PACK
ttt. ENT PACK
uuu. BEC MOHS PACK
vvv. PK,ENT-EAR
www. SVMMC HEAD AND NECK PACK
xxx. PK, ENT
yyy. HEAD AND NECK PACK
zzz. FESS PACK
aaaa. PK,ENT-SINUS
bbbb. NASAL/HEAD & NECK PACK
cccc. ENT PACK
dddd. ENT PACK
eeee. MAJOR ENT PACK
ffff. ENT NECK MMC PACK
gggg. HEAD AND NECK PACK
hhhh. HEAD AND NECK PACK
iiii. HEAD AND NECK PACK
jjjj. ORAL PACK
kkkk. HMT THORACOSCOPY PACK
llll. GU PACK
mmmm. HEAD NECKPACK (HNSJC)227-LF
nnnn. HEAD AND NECK PLUS I PACK
oooo. NASAL PACK
pppp. HEAD & NECK PACK-RFD-LF
qqqq. ENT PACK
rrrr. ENT/H&N PACK
ssss. C-SECTION PACK
tttt. ENT PACK
uuuu. ENT PACK
vvvv. ENT PACK
wwww. NASAL ENT PACK
xxxx. SINUS PACK
yyyy. HEAD/NECK PACK
zzzz. ENT PACK
aaaaa. NASAL PACK
bbbbb. FESS PACK
ccccc. NASAL SEPTOPLASTY PACK
ddddd. ENT PACK
eeeee. HEAD&NECK
fffff. EAR PACK-LF
ggggg. HEAD AND NECK PACK-LF
hhhhh. EAR BASIC PACK
iiiii. HEAD AND NECK PACK
jjjjj. ENT/SEPTO PACK
kkkkk. ENT PACK
lllll. HEAD & NECK PACK
mmmmm. HEAD AND NECK PACK
nnnnn. ENT PACK
ooooo. ENT PACK-LF
ppppp. ENT PACK-LF
qqqqq. HL DR PETERS ENT PACK
rrrrr. RHINO/SEPTO/FESS PACK
sssss. HEAD & NECK
ttttt. THYROID/PARATHYROID PACK
uuuuu. HEAD AND NECK MINOR PACK
vvvvv. PK,ENT
wwwww. ENT PACK
xxxxx. ENT PACK
yyyyy. ENT PACK
zzzzz. ENT NECK PACK
aaaaaa. ENT PACK
bbbbbb. NECK PACK
cccccc. EAR TRAY
dddddd. HEAD & NECK PACK
eeeeee. HEAD & NECK PACK
ffffff. MHPB HEAD AND NECK PACK
gggggg. NASAL PACK
hhhhhh. ENT PACK
iiiiii. JHOC EAR TRAY
jjjjjj. JHOC HEAD TRAY
kkkkkk. ENT I
llllll. ENT SHARED
mmmmmm. ENT PACK
nnnnnn. EENT SPLIT PACK-NO GPAD
oooooo. ENT PACK
pppppp. HEAD & NECK PACK
qqqqqq. NASAL PACK
rrrrrr. ENT PACK
ssssss. ENT PACK
tttttt. ENT PACK
uuuuuu. ENT PACK
vvvvvv. ENT PACK-LF
wwwwww. ENT I-LF
xxxxxx. MAJOR HEAD AND NECK PACK
yyyyyy. HEAD AND NECK PACK
zzzzzz. FACE AND NECK
aaaaaaa. ENT PACK
bbbbbbb. ENT PACK
ccccccc. ENT BASIC PACK-LF
ddddddd. ENT PACK-LF
eeeeeee. PK, ENT-H&N
fffffff. ENT PACK
ggggggg. SPRINGS HEAD AND NECK PACK
hhhhhhh. ENDO SINUS PACK
iiiiiii. HEAD/NECK PACK
jjjjjjj. ENT/SINUS PACK-LF
kkkkkkk. ENT PACK
lllllll. NASAL PACK
mmmmmmm. ENT PACK
nnnnnnn. ORAL PLASTIC FACIAL PACK
ooooooo. ENT HEAD NECK PACK
ppppppp. THYROIDECTOMY PACK
qqqqqqq. MINOR ORL PACK
rrrrrrr. EAR CUSTOM PACK
sssssss. MG NS ENT PACK
ttttttt. HEAD AND NECK PACK
uuuuuuu. ENT PACK
vvvvvvv. MAJOR ENT PACK
wwwwwww. ENT
xxxxxxx. NASAL EAR
yyyyyyy. NASAL-LF
zzzzzzz. LARGE ENT
aaaaaaaa. EAR
bbbbbbbb. HEAD AND NECK
cccccccc. PAD ENT HEAD & NECK
dddddddd. FHT CVOR TAVR
eeeeeeee. MODULE NASAL NATALIE
ffffffff. ENT-LF
gggggggg. HEA |
|---|
| Code Information |
a. EAR CDS-LF, Item Number: CDS982612B, Case UDI/GTIN: 40888277899729, Unit UDI/GTIN: 10888277899728, Lot Number: 22JBH351,22JBA043;
b. SINUS CDS-1, Item Number: CDS982901F, Case UDI/GTIN: 40889942216971, Unit UDI/GTIN: 10889942216970, Lot Number: 22KBD129;
c. ZALE FESS CDS, Item Number: CDS983178F, Case UDI/GTIN: 40195327164639, Unit UDI/GTIN: 10195327164638, Lot Number: 22JBC334,22IBC429;
d. ZALE OTOLOGY CDS, Item Number: CDS983181F, Case UDI/GTIN: 40195327164646, Unit UDI/GTIN: 10195327164645, Lot Number: 22IBQ523,22IBJ058;
e. ZALE HEAD & NECK CDS, Item Number: CDS983184I, Case UDI/GTIN: 40195327178353, Unit UDI/GTIN: 10195327178352, Lot Number: 22IBO795,22IBJ687;
f. CUH PARA/THYROIDECTOMY CDS, Item Number: CDS983209J, Case UDI/GTIN: 40195327179794, Unit UDI/GTIN: 10195327179793, Lot Number: 22JBC280;
g. CAM ENDOSCOPIC SINUS/SEPTO CDS, Item Number: CDS983499D, Case UDI/GTIN: 40193489749756, Unit UDI/GTIN: 10193489749755, Lot Number: 22IBU380,22HBW179;
h. HEAD AND NECK CDS, Item Number: CDS983910K, Case UDI/GTIN: 40195327256594, Unit UDI/GTIN: 10195327256593, Lot Number: 22JBT244;
i. HEAD AND NECK CDS-LF, Item Number: CDS984857J, Case UDI/GTIN: 40195327090808, Unit UDI/GTIN: 10195327090807, Lot Number: 22JDB038,22IDA739;
j. NASAL, Item Number: CDS984899G, Case UDI/GTIN: 40193489983822, Unit UDI/GTIN: 10193489983821, Lot Number: 22IBC505;
k. ENT SET UP CDS, Item Number: CDS985421G, Case UDI/GTIN: 40193489319300, Unit UDI/GTIN: 10193489319309, Lot Number: 22KBG050,22HBX042;
l. MINOR ENT SINUS PACK-LF, Item Number: DYNJ0101278F, Case UDI/GTIN: 40193489352352, Unit UDI/GTIN: 10193489352351, Lot Number: 22HDC403;
m. MAJOR EAR PACK-LF, Item Number: DYNJ0101314C, Case UDI/GTIN: 40193489451093, Unit UDI/GTIN: 10193489451092, Lot Number: 22JDA679,22HDC440;
n. THORACOTOMY HARPER PACK-LF, Item Number: DYNJ0161795C, Case UDI/GTIN: 40889942216629, Unit UDI/GTIN: 10889942216628, Lot Number: 22IDB179;
o. FESS NSR PACK-LF, Item Number: DYNJ0381496I, Case UDI/GTIN: 40193489475310, Unit UDI/GTIN: 10193489475319, Lot Number: 22JBH235;
p. ENT BASIC PACK-LF, Item Number: DYNJ0387711D, Case UDI/GTIN: 40195327270156, Unit UDI/GTIN: 10195327270155, Lot Number: 22JMI201;
q. HEAD & NECK-LF, Item Number: DYNJ04437J, Case UDI/GTIN: 40193489274494, Unit UDI/GTIN: 10193489274493, Lot Number: 22JMI207;
r. ENT PACK-LF, Item Number: DYNJ04591F, Case UDI/GTIN: 40193489551434, Unit UDI/GTIN: 10193489551433, Lot Number: 22JMH877;
s. SINOSCOPY-LF, Item Number: DYNJ06621D, Case UDI/GTIN: 40888277854698, Unit UDI/GTIN: 10888277854697, Lot Number: 22JBM104,22HBX999;
t. MAJOR HEAD/NECK PACK-LF, Item Number: DYNJ0826705N, Case UDI/GTIN: 40193489265683, Unit UDI/GTIN: 10193489265682, Lot Number: 22JMD563,22JMD586;
u. NECK PACK, Item Number: DYNJ13175, Case UDI/GTIN: 40195327215782, Unit UDI/GTIN: 10195327215781, Lot Number: 22JBG041;
v. HEAD & NECK PACK, Item Number: DYNJ14069B, Case UDI/GTIN: 40884389223025, Unit UDI/GTIN: 10884389223024, Lot Number: 22JBI051,22IBQ751,22IBB059;
w. HEAD & NECK TRAY, Item Number: DYNJ15653J, Case UDI/GTIN: 40193489767996, Unit UDI/GTIN: 10193489767995, Lot Number: 22JBE697;
x. ENT LAW PACK-LF, Item Number: DYNJ16428L, Case UDI/GTIN: 40195327084821, Unit UDI/GTIN: 10195327084820, Lot Number: 22JMD569,22HMB943;
y. ENT PACK, Item Number: DYNJ17203I, Case UDI/GTIN: 40193489668170, Unit UDI/GTIN: 10193489668179, Lot Number: 22IDB986;
z. NECK PACK, Item Number: DYNJ17213D, Case UDI/GTIN: 40193489668477, Unit UDI/GTIN: 10193489668476, Lot Number: 22JDA408;
aa. NASAL PACK, Item Number: DYNJ17493G, Case UDI/GTIN: 40195327224425, Unit UDI/GTIN: 10195327224424, Lot Number: 22HBR581;
bb. ENT PACK, Item Number: DYNJ19846J, Case UDI/GTIN: 40888277850997, Unit UDI/GTIN: 10888277850996, Lot Number: 22IBV046;
cc. FREE FLAP PACK-LF, Item Number: DYNJ20495J, Case UDI/GTIN: 40195327024407, Unit UDI/GTIN: 10195327024406, Lot Number: 22JDA143;
dd. TYMPANO MASTOID, Item Number: DYNJ21567A, Case UDI/GTIN: 40080196015345, Unit UDI/GTIN: 10080196015344, Lot Number: 22JBD171,22IBE475,22HBK016;
ee. MINOR HEAD & NECK #40-RF, Item Number: DYNJ21948S, Case UDI/GTIN: 40195327104727, Unit UDI/GTIN: 10195327104726, Lot Number: 22JBB180,22JBC021;
ff. EAR PACK, Item Number: DYNJ22136B, Case UDI/GTIN: 40193489228220, Unit UDI/GTIN: 10193489228229, Lot Number: 22KMA168;
gg. E.N.T. TRAY, Item Number: DYNJ22357K, Case UDI/GTIN: 40193489926737, Unit UDI/GTIN: 10193489926736, Lot Number: 22KBB868,22JBE605,22IBD335,22HBJ735;
hh. EAR PACK-LF, Item Number: DYNJ24092M, Case UDI/GTIN: 40195327024421, Unit UDI/GTIN: 10195327024420, Lot Number: 22IDA807;
ii. BASIC ENT PACK-LF, Item Number: DYNJ24912K, Case UDI/GTIN: 40193489992862, Unit UDI/GTIN: 10193489992861, Lot Number: 22IBL139,22HBV866,22HBU453,22HBT633,22HBP897;
jj. PLASTIC HEAD & NECK PACK, Item Number: DYNJ24941M, Case UDI/GTIN: 40889942176329, Unit UDI/GTIN: 10889942176328, Lot Number: 22IDC167;
kk. EAR TRAY #10-RF, Item Number: DYNJ27428R, Case UDI/GTIN: 40195327114900, Unit UDI/GTIN: 10195327114909, Lot Number: 22JBI743;
ll. HEAD & NECK ENT PACK-RF-LF, Item Number: DYNJ30604P, Case UDI/GTIN: 40193489962834, Unit UDI/GTIN: 10193489962833, Lot Number: 22IBU329,22IBU962;
mm. ENT PACK, Item Number: DYNJ30988C, Case UDI/GTIN: 40889942715719, Unit UDI/GTIN: 10889942715718, Lot Number: 22IBI164;
nn. ENT PACK-LF, Item Number: DYNJ31584I, Case UDI/GTIN: 40193489504416, Unit UDI/GTIN: 10193489504415, Lot Number: 22JME741,22IMG343;
oo. NASAL/SEPTO PACK, Item Number: DYNJ32099, Case UDI/GTIN: 40884389092911, Unit UDI/GTIN: 10884389092910, Lot Number: 22KBA569;
pp. OSC FACE LIFT PK, Item Number: DYNJ32855B, Case UDI/GTIN: 40889942465218, Unit UDI/GTIN: 10889942465217, Lot Number: 22IBH454;
qq. RRMC NASAL PACK, Item Number: DYNJ33396G, Case UDI/GTIN: 40193489914574, Unit UDI/GTIN: 10193489914573, Lot Number: 22JMD009;
rr. ENT PACK, Item Number: DYNJ33698D, Case UDI/GTIN: 40889942689355, Unit UDI/GTIN: 10889942689354, Lot Number: 22JBY709,22IBF415;
ss. HENRYS ENT PACK, Item Number: DYNJ34093F, Case UDI/GTIN: 40193489274685, Unit UDI/GTIN: 10193489274684, Lot Number: 22JMC221;
tt. ENT, Item Number: DYNJ34426I, Case UDI/GTIN: 40193489224703, Unit UDI/GTIN: 10193489224702, Lot Number: 22JMA985;
uu. FACE AND NASAL PACK, Item Number: DYNJ35554B, Case UDI/GTIN: 40195327097869, Unit UDI/GTIN: 10195327097868, Lot Number: 22IBQ641;
vv. NASAL PACK, Item Number: DYNJ35803A, Case UDI/GTIN: 40889942557210, Unit UDI/GTIN: 10889942557219, Lot Number: 22JBE657;
ww. ENT PACK, Item Number: DYNJ36516, Case UDI/GTIN: 40884389544113, Unit UDI/GTIN: 10884389544112, Lot Number: 22HBS907;
xx. SINUS ENDOSCOPY-LF, Item Number: DYNJ36720D, Case UDI/GTIN: 40195327148684, Unit UDI/GTIN: 10195327148683, Lot Number: 22JBA686;
yy. OSC NASAL-NOSE PACK-LF, Item Number: DYNJ37383C, Case UDI/GTIN: 40889942465256, Unit UDI/GTIN: 10889942465255, Lot Number: 22JBA361,22HBN245,22HBN978,22HBL526;
zz. ENT PACK, Item Number: DYNJ38321D, Case UDI/GTIN: 40195327103591, Unit UDI/GTIN: 10195327103590, Lot Number: 22JBQ451;
aaa. FES PACK - LF, Item Number: DYNJ38730C, Case UDI/GTIN: 40195327100316, Unit UDI/GTIN: 10195327100315, Lot Number: 22JMC574;
bbb. HEAD AND NECK PACK, Item Number: DYNJ38880D, Case UDI/GTIN: 40193489997331, Unit UDI/GTIN: 10193489997330, Lot Number: 22JMA087;
ccc. SCRIPPS SW ENT PACK, Item Number: DYNJ39829D, Case UDI/GTIN: 40195327176571, Unit UDI/GTIN: 10195327176570, Lot Number: 22IMI295,22HME428;
ddd. SCRIPPS SW EAR PACK-LF, Item Number: DYNJ39858B, Case UDI/GTIN: 40195327179466, Unit UDI/GTIN: 10195327179465, Lot Number: 22JMA176;
eee. HL ENT PACK, Item Number: DYNJ40360D, Case UDI/GTIN: 40889942697176, Unit UDI/GTIN: 10889942697175, Lot Number: 22JBL587,22IBS429,22IBU440;
fff. CAROTID ENDARTECTOMY PK, Item Number: DYNJ40386B, Case UDI/GTIN: 40889942215769, Unit UDI/GTIN: 10889942215768, Lot Number: 22IBP925;
ggg. EAR PACK, Item Number: DYNJ40401B, Case UDI/GTIN: 40193489231527, Unit UDI/GTIN: 10193489231526, Lot Number: 22JBI621,22HBS976,22HBK587;
hhh. ENT FREE FLAP, Item Number: DYNJ40403D, Case UDI/GTIN: 40193489373531, Unit UDI/GTIN: 10193489373530, Lot Number: 22IBU477,22HBT008;
iii. HEAD AND NECK PACK, Item Number: DYNJ40411A, Case UDI/GTIN: 40889942216094, Unit UDI/GTIN: 10889942216093, Lot Number: 22JBI783,22IBG980,22HBI781;
jjj. TRACH PACK, Item Number: DYNJ40431A, Case UDI/GTIN: 40889942215691, Unit UDI/GTIN: 10889942215690, Lot Number: 22JBP822,22HBS909;
kkk. HL EAR PACK, Item Number: DYNJ40560A, Case UDI/GTIN: 40889942529897, Unit UDI/GTIN: 10889942529896, Lot Number: 22HBZ367;
lll. NASAL SINUS ENDO PK, Item Number: DYNJ41024C, Case UDI/GTIN: 40889942233466, Unit UDI/GTIN: 10889942233465, Lot Number: 22IBS024;
mmm. ENT PACK, Item Number: DYNJ41060A, Case UDI/GTIN: 40195327025428, Unit UDI/GTIN: 10195327025427, Lot Number: 22IBQ559,22IBL826,22IBL050;
nnn. HEAD AND NECK PACK, Item Number: DYNJ41270B, Case UDI/GTIN: 40193489789080, Unit UDI/GTIN: 10193489789089, Lot Number: 22JMB156,22JMB478,22JMA301;
ooo. ENT PACK, Item Number: DYNJ41327C, Case UDI/GTIN: 40193489923156, Unit UDI/GTIN: 10193489923155, Lot Number: 22JBW436,22HBI717;
ppp. HEAD AND NECK PACK, Item Number: DYNJ42004B, Case UDI/GTIN: 40888277918239, Unit UDI/GTIN: 10888277918238, Lot Number: 22JMC585;
qqq. ASC HEAD & NECK PACK, Item Number: DYNJ42019B, Case UDI/GTIN: 40888277938329, Unit UDI/GTIN: 10888277938328, Lot Number: 22IBM163,22HBL313;
rrr. ENT PACK, Item Number: DYNJ42228B, Case UDI/GTIN: 40193489878975, Unit UDI/GTIN: 10193489878974, Lot Number: 22IMB508;
sss. DEACONESS HEAD AND NECK PACK, Item Number: DYNJ42242, Case UDI/GTIN: 40884389921280, Unit UDI/GTIN: 10884389921289, Lot Number: 22HBY134,22HBZ333;
ttt. ENT PACK, Item Number: DYNJ42564B, Case UDI/GTIN: 40193489685047, Unit UDI/GTIN: 10193489685046, Lot Number: 22IBC952;
uuu. BEC MOHS PACK, Item Number: DYNJ43111G, Case UDI/GTIN: 40195327007615, Unit UDI/GTIN: 10195327007614, Lot Number: 22JBK014;
vvv. PK,ENT-EAR, Item Number: DYNJ43700A, Case UDI/GTIN: 40193489332194, Unit UDI/GTIN: 10193489332193, Lot Number: 22HBS025,22HBP684;
www. SVMMC HEAD AND NECK PACK, Item Number: DYNJ43776G, Case UDI/GTIN: 40193489989718, Unit UDI/GTIN: 10193489989717, Lot Number: 22JBG530,22JBD640;
xxx. PK, ENT, Item Number: DYNJ43875B, Case UDI/GTIN: 40193489427876, Unit UDI/GTIN: 10193489427875, Lot Number: 22JBM105,22IBC196;
yyy. HEAD AND NECK PACK, Item Number: DYNJ44019B, Case UDI/GTIN: 40193489795081, Unit UDI/GTIN: 10193489795080, Lot Number: 22HBY533,22HBM204;
zzz. FESS PACK, Item Number: DYNJ44080A, Case UDI/GTIN: 40888277279774, Unit UDI/GTIN: 10888277279773, Lot Number: 22IBV695;
aaaa. PK,ENT-SINUS, Item Number: DYNJ45036D, Case UDI/GTIN: 40193489259903, Unit UDI/GTIN: 10193489259902, Lot Number: 22JBF806,22HBG764;
bbbb. NASAL/HEAD & NECK PACK, Item Number: DYNJ45078C, Case UDI/GTIN: 40195327045204, Unit UDI/GTIN: 10195327045203, Lot Number: 22JBL812,22JBL819;
cccc. ENT PACK, Item Number: DYNJ45175B, Case UDI/GTIN: 40889942485216, Unit UDI/GTIN: 10889942485215, Lot Number: 22HLA901;
dddd. ENT PACK, Item Number: DYNJ45260B, Case UDI/GTIN: 40193489852449, Unit UDI/GTIN: 10193489852448, Lot Number: 22JBU804;
eeee. MAJOR ENT PACK, Item Number: DYNJ45576B, Case UDI/GTIN: 40195327059201, Unit UDI/GTIN: 10195327059200, Lot Number: 22JBD150,22IBS180;
ffff. ENT NECK MMC PACK, Item Number: DYNJ46091G, Case UDI/GTIN: 40193489496452, Unit UDI/GTIN: 10193489496451, Lot Number: 22HDB941;
gggg. HEAD AND NECK PACK, Item Number: DYNJ46216I, Case UDI/GTIN: 40195327160341, Unit UDI/GTIN: 10195327160340, Lot Number: 22JBE614,22JBE616,22IBI293;
hhhh. HEAD AND NECK PACK, Item Number: DYNJ46486B, Case UDI/GTIN: 40193489472159, Unit UDI/GTIN: 10193489472158, Lot Number: 22IBH413;
iiii. HEAD AND NECK PACK, Item Number: DYNJ46509G, Case UDI/GTIN: 40195327001002, Unit UDI/GTIN: 10195327001001, Lot Number: 22HMD805;
jjjj. ORAL PACK, Item Number: DYNJ46541J, Case UDI/GTIN: 40195327067909, Unit UDI/GTIN: 10195327067908, Lot Number: 22HME315;
kkkk. HMT THORACOSCOPY PACK, Item Number: DYNJ47230K, Case UDI/GTIN: 40193489839259, Unit UDI/GTIN: 10193489839258, Lot Number: 22IBF197;
llll. GU PACK, Item Number: DYNJ47244B, Case UDI/GTIN: 40888277896445, Unit UDI/GTIN: 10888277896444, Lot Number: 22JBE709;
mmmm. HEAD NECKPACK (HNSJC)227-LF, Item Number: DYNJ47489B, Case UDI/GTIN: 40193489836821, Unit UDI/GTIN: 10193489836820, Lot Number: 22JMD474;
nnnn. HEAD AND NECK PLUS I PACK, Item Number: DYNJ47635B, Case UDI/GTIN: 40193489731003, Unit UDI/GTIN: 10193489731002, Lot Number: 22HBI260;
oooo. NASAL PACK, Item Number: DYNJ47753D, Case UDI/GTIN: 40193489859325, Unit UDI/GTIN: 10193489859324, Lot Number: 22IMI004;
pppp. HEAD & NECK PACK-RFD-LF, Item Number: DYNJ47765J, Case UDI/GTIN: 40193489768085, Unit UDI/GTIN: 10193489768084, Lot Number: 22IMG240,22HMD477;
qqqq. ENT PACK, Item Number: DYNJ47847C, Case UDI/GTIN: 40889942234296, Unit UDI/GTIN: 10889942234295, Lot Number: 22HBM628;
rrrr. ENT/H&N PACK, Item Number: DYNJ48442D, Case UDI/GTIN: 40888277764508, Unit UDI/GTIN: 10888277764507, Lot Number: 22HMC400;
ssss. C-SECTION PACK, Item Number: DYNJ48455A, Case UDI/GTIN: 40889942754497, Unit UDI/GTIN: 10889942754496, Lot Number: 22HBR925,22HBR422,22HBG075;
tttt. ENT PACK, Item Number: DYNJ48595, Case UDI/GTIN: 40888277915184, Unit UDI/GTIN: 10888277915183, Lot Number: 22JBE666;
uuuu. ENT PACK, Item Number: DYNJ48856D, Case UDI/GTIN: 40889942975472, Unit UDI/GTIN: 10889942975471, Lot Number: 22IBC410,22HBX258;
vvvv. ENT PACK, Item Number: DYNJ48856F, Case UDI/GTIN: 40195327260188, Unit UDI/GTIN: 10195327260187, Lot Number: 22JBC693;
wwww. NASAL ENT PACK, Item Number: DYNJ49356, Case UDI/GTIN: 40888277846785, Unit UDI/GTIN: 10888277846784, Lot Number: 22IBF462,22IBB028;
xxxx. SINUS PACK, Item Number: DYNJ50110B, Case UDI/GTIN: 40889942794943, Unit UDI/GTIN: 10889942794942, Lot Number: 22HME087;
yyyy. HEAD/NECK PACK, Item Number: DYNJ50297A, Case UDI/GTIN: 40889942302582, Unit UDI/GTIN: 10889942302581, Lot Number: 22IBK191,22HBZ267;
zzzz. ENT PACK, Item Number: DYNJ50502G, Case UDI/GTIN: 40888277765901, Unit UDI/GTIN: 10888277765900, Lot Number: 22JBF009,22JBD205,22HBR406;
aaaaa. NASAL PACK, Item Number: DYNJ50533C, Case UDI/GTIN: 40193489896764, Unit UDI/GTIN: 10193489896763, Lot Number: 22HBM477;
bbbbb. FESS PACK, Item Number: DYNJ50596B, Case UDI/GTIN: 40193489864909, Unit UDI/GTIN: 10193489864908, Lot Number: 22IBK682;
ccccc. NASAL SEPTOPLASTY PACK, Item Number: DYNJ50960I, Case UDI/GTIN: 40195327065639, Unit UDI/GTIN: 10195327065638, Lot Number: 22HBP168;
ddddd. ENT PACK, Item Number: DYNJ51934A, Case UDI/GTIN: 40193489584777, Unit UDI/GTIN: 10193489584776, Lot Number: 22JMG827;
eeeee. HEAD&NECK, Item Number: DYNJ52015, Case UDI/GTIN: 40889942233077, Unit UDI/GTIN: 10889942233076, Lot Number: 22IBL671;
fffff. EAR PACK-LF, Item Number: DYNJ52043B, Case UDI/GTIN: 40195327096305, Unit UDI/GTIN: 10195327096304, Lot Number: 22JBV651;
ggggg. HEAD AND NECK PACK-LF, Item Number: DYNJ52047B, Case UDI/GTIN: 40195327096060, Unit UDI/GTIN: 10195327096069, Lot Number: 22JBL899;
hhhhh. EAR BASIC PACK, Item Number: DYNJ52099G, Case UDI/GTIN: 40195327035250, Unit UDI/GTIN: 10195327035259, Lot Number: 22JBW666,22JBH682;
iiiii. HEAD AND NECK PACK, Item Number: DYNJ52101D, Case UDI/GTIN: 40195327079902, Unit UDI/GTIN: 10195327079901, Lot Number: 22IBR398;
jjjjj. ENT/SEPTO PACK, Item Number: DYNJ52102C, Case UDI/GTIN: 40195327035267, Unit UDI/GTIN: 10195327035266, Lot Number: 22IBK213,22HBT012;
kkkkk. ENT PACK, Item Number: DYNJ52641C, Case UDI/GTIN: 40195327125548, Unit UDI/GTIN: 10195327125547, Lot Number: 22JME346,22CBY373;
lllll. HEAD & NECK PACK, Item Number: DYNJ52758F, Case UDI/GTIN: 40193489929479, Unit UDI/GTIN: 10193489929478, Lot Number: 22HBX064,22HBR162;
mmmmm. HEAD AND NECK PACK, Item Number: DYNJ52867C, Case UDI/GTIN: 40195327048137, Unit UDI/GTIN: 10195327048136, Lot Number: 22IBQ656;
nnnnn. ENT PACK, Item Number: DYNJ53413, Case UDI/GTIN: 40889942421085, Unit UDI/GTIN: 10889942421084, Lot Number: 22KBA262;
ooooo. ENT PACK-LF, Item Number: DYNJ54443C, Case UDI/GTIN: 40889942925637, Unit UDI/GTIN: 10889942925636, Lot Number: 22IBG086;
ppppp. ENT PACK-LF, Item Number: DYNJ54911B, Case UDI/GTIN: 40193489317054, Unit UDI/GTIN: 10193489317053, Lot Number: 22JBK448,22IBO920,22HBR955;
qqqqq. HL DR PETERS ENT PACK, Item Number: DYNJ55161, Case UDI/GTIN: 40889942530640, Unit UDI/GTIN: 10889942530649, Lot Number: 22JBQ711,22IBL566;
rrrrr. RHINO/SEPTO/FESS PACK, Item Number: DYNJ55955F, Case UDI/GTIN: 40195327023660, Unit UDI/GTIN: 10195327023669, Lot Number: 22IBB402,22HBU443;
sssss. HEAD & NECK, Item Number: DYNJ56352D, Case UDI/GTIN: 40193489891417, Unit UDI/GTIN: 10193489891416, Lot Number: 22HMF122;
ttttt. THYROID/PARATHYROID PACK, Item Number: DYNJ56989B, Case UDI/GTIN: 40193489997423, Unit UDI/GTIN: 10193489997422, Lot Number: 22IDB856;
uuuuu. HEAD AND NECK MINOR PACK, Item Number: DYNJ57500A, Case UDI/GTIN: 40193489997386, Unit UDI/GTIN: 10193489997385, Lot Number: 22JBG027,22JBD520,22JBE591;
vvvvv. PK,ENT, Item Number: DYNJ57583, Case UDI/GTIN: 40889942755333, Unit UDI/GTIN: 10889942755332, Lot Number: 22IBF900;
wwwww. ENT PACK, Item Number: DYNJ57639A, Case UDI/GTIN: 40193489985055, Unit UDI/GTIN: 10193489985054, Lot Number: 22JMC352;
xxxxx. ENT PACK, Item Number: DYNJ58613, Case UDI/GTIN: 40889942872207, Unit UDI/GTIN: 10889942872206, Lot Number: 22HBU133;
yyyyy. ENT PACK, Item Number: DYNJ58955, Case UDI/GTIN: 40889942913290, Unit UDI/GTIN: 10889942913299, Lot Number: 22JMF041;
zzzzz. ENT NECK PACK, Item Number: DYNJ59339B, Case UDI/GTIN: 40193489912402, Unit UDI/GTIN: 10193489912401, Lot Number: 22HMC555;
aaaaaa. ENT PACK, Item Number: DYNJ59447A, Case UDI/GTIN: 40193489707664, Unit UDI/GTIN: 10193489707663, Lot Number: 22IBE517;
bbbbbb. NECK PACK, Item Number: DYNJ60653A, Case UDI/GTIN: 40195327100286, Unit UDI/GTIN: 10195327100285, Lot Number: 22HME148;
cccccc. EAR TRAY, Item Number: DYNJ60743F, Case UDI/GTIN: 40193489221443, Unit UDI/GTIN: 10193489221442, Lot Number: 22IBD747;
dddddd. HEAD & NECK PACK, Item Number: DYNJ61295B, Case UDI/GTIN: 40193489809139, Unit UDI/GTIN: 10193489809138, Lot Number: 22HBN475;
eeeeee. HEAD & NECK PACK, Item Number: DYNJ61295C, Case UDI/GTIN: 40195327246915, Unit UDI/GTIN: 10195327246914, Lot Number: 22IBH189;
ffffff. MHPB HEAD AND NECK PACK, Item Number: DYNJ62032B, Case UDI/GTIN: 40195327058280, Unit UDI/GTIN: 10195327058289, Lot Number: 22JBC723,22HBR741;
gggggg. NASAL PACK, Item Number: DYNJ62057C, Case UDI/GTIN: 40195327038503, Unit UDI/GTIN: 10195327038502, Lot Number: 22JBW712;
hhhhhh. ENT PACK, Item Number: DYNJ62476B, Case UDI/GTIN: 40193489899796, Unit UDI/GTIN: 10193489899795, Lot Number: 22HBY505;
iiiiii. JHOC EAR TRAY, Item Number: DYNJ62763A, Case UDI/GTIN: 40193489755955, Unit UDI/GTIN: 10193489755954, Lot Number: 22JBG830;
jjjjjj. JHOC HEAD TRAY, Item Number: DYNJ62764A, Case UDI/GTIN: 40193489755962, Unit UDI/GTIN: 10193489755961, Lot Number: 22IBR805,22HBY155;
kkkkkk. ENT I, Item Number: DYNJ63781A, Case UDI/GTIN: 40195327213115, Unit UDI/GTIN: 10195327213114, Lot Number: 22HMC704;
llllll. ENT SHARED, Item Number: DYNJ64782B, Case UDI/GTIN: 40195327217700, Unit UDI/GTIN: 10195327217709, Lot Number: 22JDB161,22HDC318;
mmmmmm. ENT PACK, Item Number: DYNJ66178B, Case UDI/GTIN: 40193489986342, Unit UDI/GTIN: 10193489986341, Lot Number: 22JBE823,22HBM481;
nnnnnn. EENT SPLIT PACK-NO GPAD, Item Number: DYNJ66249, Case UDI/GTIN: 40193489324755, Unit UDI/GTIN: 10193489324754, Lot Number: 22JBY465;
oooooo. ENT PACK, Item Number: DYNJ66379, Case UDI/GTIN: 40193489347693, Unit UDI/GTIN: 10193489347692, Lot Number: 22HMF906;
pppppp. HEAD & NECK PACK, Item Number: DYNJ66399, Case UDI/GTIN: 40193489351430, Unit UDI/GTIN: 10193489351439, Lot Number: 22HBO944;
qqqqqq. NASAL PACK, Item Number: DYNJ66514, Case UDI/GTIN: 40193489359283, Unit UDI/GTIN: 10193489359282, Lot Number: 22JBG484;
rrrrrr. ENT PACK, Item Number: DYNJ66570, Case UDI/GTIN: 40193489360630, Unit UDI/GTIN: 10193489360639, Lot Number: 22IBU414;
ssssss. ENT PACK, Item Number: DYNJ67751B, Case UDI/GTIN: 40195327029686, Unit UDI/GTIN: 10195327029685, Lot Number: 22JMF955;
tttttt. ENT PACK, Item Number: DYNJ67775A, Case UDI/GTIN: 40193489996259, Unit UDI/GTIN: 10193489996258, Lot Number: 22HBU117;
uuuuuu. ENT PACK, Item Number: DYNJ67824A, Case UDI/GTIN: 40193489495004, Unit UDI/GTIN: 10193489495003, Lot Number: 22IBR987;
vvvvvv. ENT PACK-LF, Item Number: DYNJ67992, Case UDI/GTIN: 40193489462624, Unit UDI/GTIN: 10193489462623, Lot Number: 22IBJ809,22HBM177;
wwwwww. ENT I-LF, Item Number: DYNJ68364A, Case UDI/GTIN: 40195327024513, Unit UDI/GTIN: 10195327024512, Lot Number: 22JBE689;
xxxxxx. MAJOR HEAD AND NECK PACK, Item Number: DYNJ68819A, Case UDI/GTIN: 40195327159536, Unit UDI/GTIN: 10195327159535, Lot Number: 22HBN411;
yyyyyy. HEAD AND NECK PACK, Item Number: DYNJ68872A, Case UDI/GTIN: 40195327181391, Unit UDI/GTIN: 10195327181390, Lot Number: 22JBO613;
zzzzzz. FACE AND NECK, Item Number: DYNJ69446A, Case UDI/GTIN: 40195327264810, Unit UDI/GTIN: 10195327264819, Lot Number: 22KBA528;
aaaaaaa. ENT PACK, Item Number: DYNJ69486, Case UDI/GTIN: 40193489948579, Unit UDI/GTIN: 10193489948578, Lot Number: 22HME759;
bbbbbbb. ENT PACK, Item Number: DYNJ69558A, Case UDI/GTIN: 40195327225170, Unit UDI/GTIN: 10195327225179, Lot Number: 22IBP115,22HBT948;
ccccccc. ENT BASIC PACK-LF, Item Number: DYNJ69587A, Case UDI/GTIN: 40195327040391, Unit UDI/GTIN: 10195327040390, Lot Number: 22HME707;
ddddddd. ENT PACK-LF, Item Number: DYNJ69688, Case UDI/GTIN: 40193489969871, Unit UDI/GTIN: 10193489969870, Lot Number: 22JBE810,22HBI625;
eeeeeee. PK, ENT-H&N, Item Number: DYNJ69851, Case UDI/GTIN: 40193489985857, Unit UDI/GTIN: 10193489985856, Lot Number: 22JME416,22HMH023;
fffffff. ENT PACK, Item Number: DYNJ69890A, Case UDI/GTIN: 40195327235124, Unit UDI/GTIN: 10195327235123, Lot Number: 22IBR761,22HBU119;
ggggggg. SPRINGS HEAD AND NECK PACK, Item Number: DYNJ69930, Case UDI/GTIN: 40193489997775, Unit UDI/GTIN: 10193489997774, Lot Number: 22IMI536,22HME709;
hhhhhhh. ENDO SINUS PACK, Item Number: DYNJ69950A, Case UDI/GTIN: 40195327175703, Unit UDI/GTIN: 10195327175702, Lot Number: 22IBO306;
iiiiiii. HEAD/NECK PACK, Item Number: DYNJ81402, Case UDI/GTIN: 40195327116768, Unit UDI/GTIN: 10195327116767, Lot Number: 22JBT150,22EBF640;
jjjjjjj. ENT/SINUS PACK-LF, Item Number: DYNJ81820, Case UDI/GTIN: 40195327147250, Unit UDI/GTIN: 10195327147259, Lot Number: 22JBX949;
kkkkkkk. ENT PACK, Item Number: DYNJ82137, Case UDI/GTIN: 40195327176670, Unit UDI/GTIN: 10195327176679, Lot Number: 22HBF358;
lllllll. NASAL PACK, Item Number: DYNJ82476, Case UDI/GTIN: 40195327197217, Unit UDI/GTIN: 10195327197216, Lot Number: 22HBR242;
mmmmmmm. ENT PACK, Item Number: DYNJ82492, Case UDI/GTIN: 40195327197484, Unit UDI/GTIN: 10195327197483, Lot Number: 22JBR187,22HBF736;
nnnnnnn. ORAL PLASTIC FACIAL PACK, Item Number: DYNJ82506, Case UDI/GTIN: 40195327198313, Unit UDI/GTIN: 10195327198312, Lot Number: 22HBI367;
ooooooo. ENT HEAD NECK PACK, Item Number: DYNJ82508, Case UDI/GTIN: 40195327198337, Unit UDI/GTIN: 10195327198336, Lot Number: 22HBH557;
ppppppp. THYROIDECTOMY PACK, Item Number: DYNJ82520, Case UDI/GTIN: 40195327198368, Unit UDI/GTIN: 10195327198367, Lot Number: 22IBF364;
qqqqqqq. MINOR ORL PACK, Item Number: DYNJ82563, Case UDI/GTIN: 40195327197996, Unit UDI/GTIN: 10195327197995, Lot Number: 22HBR212;
rrrrrrr. EAR CUSTOM PACK, Item Number: DYNJ82564, Case UDI/GTIN: 40195327198009, Unit UDI/GTIN: 10195327198008, Lot Number: 22HBQ040;
sssssss. MG NS ENT PACK, Item Number: DYNJ82590, Case UDI/GTIN: 40195327198818, Unit UDI/GTIN: 10195327198817, Lot Number: 22HBS185;
ttttttt. HEAD AND NECK PACK, Item Number: DYNJ82641, Case UDI/GTIN: 40195327199402, Unit UDI/GTIN: 10195327199401, Lot Number: 22IBF695;
uuuuuuu. ENT PACK, Item Number: DYNJ83139, Case UDI/GTIN: 40195327233717, Unit UDI/GTIN: 10195327233716, Lot Number: 22JBV408;
vvvvvvv. MAJOR ENT PACK, Item Number: DYNJ83214, Case UDI/GTIN: 40195327245550, Unit UDI/GTIN: 10195327245559, Lot Number: 22JMD344;
wwwwwww. ENT, Item Number: DYNJ901051F, Case UDI/GTIN: 40195327110803, Unit UDI/GTIN: 10195327110802, Lot Number: 22JBR735,22JBD787;
xxxxxxx. NASAL EAR, Item Number: DYNJ901679F, Case UDI/GTIN: 40193489812238, Unit UDI/GTIN: 10193489812237, Lot Number: 22JBQ036;
yyyyyyy. NASAL-LF, Item Number: DYNJ901749F, Case UDI/GTIN: 40193489604352, Unit UDI/GTIN: 10193489604351, Lot Number: 22IDB506;
zzzzzzz. LARGE ENT, Item Number: DYNJ901761J, Case UDI/GTIN: 40195327091447, Unit UDI/GTIN: 10195327091446, Lot Number: 22KBE703,22JBA939,22IBS612;
aaaaaaaa. EAR, Item Number: DYNJ901779J, Case UDI/GTIN: 40193489979740, Unit UDI/GTIN: 10193489979749, Lot Number: 22JBY312,22JBY313,22IBS613;
bbbbbbbb. HEAD AND NECK, Item Number: DYNJ902108K, Case UDI/GTIN: 40193489969017, Unit UDI/GTIN: 10193489969016, Lot Number: 22IBP777;
cccccccc. PAD ENT HEAD & NECK, Item Number: DYNJ902152F, Case UDI/GTIN: 40195327149216, Unit UDI/GTIN: 10195327149215, Lot Number: 22JBR424,22JBH326,22IBA638;
dddddddd. FHT CVOR TAVR, Item Number: DYNJ902475B, Case UDI/GTIN: 40193489491471, Unit UDI/GTIN: 10193489491470, Lot Number: 22JBK902,22JBB350,22JBA002;
eeeeeeee. MODULE NASAL NATALIE, Item Number: DYNJ903036I, Case UDI/GTIN: 40193489490092, Unit UDI/GTIN: 10193489490091, Lot Number: 22HBX971;
ffffffff. ENT-LF, Item Number: DYNJ903253A, Case UDI/GTIN: 40889942632412, Unit UDI/GTIN: 10889942632411, Lot Number: 22JBW371;
gggggggg. HEAD & NECK, Item Number: DYNJ903325L, Case UDI/GTIN: 40195327236473, Unit UDI/GTIN: 10195327236472, Lot Number: 22JBE300;
hhhhhhhh. NASAL, Item Number: DYNJ903326J, Case UDI/GTIN: 40195327236480, Unit UDI/GTIN: 10195327236489, Lot Number: 22JBA437;
iiiiiiii. HEAD & NECK, Item Number: DYNJ903472G, Case UDI/GTIN: 40195327146024, Unit UDI/GTIN: 10195327146023, Lot Number: 22KDA220;
jjjjjjjj. T&A, Item Number: DYNJ903491G, Case UDI/GTIN: 40195327175598, Unit UDI/GTIN: 10195327175597, Lot Number: 22JDB890;
kkkkkkkk. ENT HEAD & NECK, Item Number: DYNJ903679F, Case UDI/GTIN: 40195327182909, Unit UDI/GTIN: 10195327182908, Lot Number: 22HBT245,22HBR343;
llllllll. HEAD AND NECK, Item Number: DYNJ903810C, Case UDI/GTIN: 40193489274135, Unit UDI/GTIN: 10193489274134, Lot Number: 22JBR487;
mmmmmmmm. GENERAL THYROID, Item Number: DYNJ903998M, Case UDI/GTIN: 40195327220885, Unit UDI/GTIN: 10195327220884, Lot Number: 22IDB065;
nnnnnnnn. ENT, Item Number: DYNJ904092C, Case UDI/GTIN: 40193489621717, Unit UDI/GTIN: 10193489621716, Lot Number: 22JDA348;
oooooooo. HEAD AND NECK, Item Number: DYNJ904283B, Case UDI/GTIN: 40195327170241, Unit UDI/GTIN: 10195327170240, Lot Number: 22KBC286;
pppppppp. ENT, Item Number: DYNJ904352D, Case UDI/GTIN: 40193489913478, Unit UDI/GTIN: 10193489913477, Lot Number: 22HBT177;
qqqqqqqq. HEART, Item Number: DYNJ905208A, Case UDI/GTIN: 40889942910008, Unit UDI/GTIN: 10889942910007, Lot Number: 22JBQ793;
rrrrrrrr. NASAL PACK, Item Number: DYNJ905563A, Case UDI/GTIN: 40193489800365, Unit UDI/GTIN: 10193489800364, Lot Number: 22KBD093;
ssssssss. SINUS, Item Number: DYNJ905843D, Case UDI/GTIN: 40195327081066, Unit UDI/GTIN: 10195327081065, Lot Number: 22JBR673,22JBK495;
tttttttt. HEAD&NECK, Item Number: DYNJ906948A, Case UDI/GTIN: 40195327128273, Unit UDI/GTIN: 10195327128272, Lot Number: 22JBP985,22IBE696;
uuuuuuuu. ENT, Item Number: DYNJ907318, Case UDI/GTIN: 40193489387699, Unit UDI/GTIN: 10193489387698, Lot Number: 22HBS474,22HBN631;
vvvvvvvv. EAR, Item Number: DYNJ907924C, Case UDI/GTIN: 40195327240029, Unit UDI/GTIN: 10195327240028, Lot Number: 22JBQ062,22HBW267;
wwwwwwww. EENT, Item Number: DYNJ907925B, Case UDI/GTIN: 40195327173181, Unit UDI/GTIN: 10195327173180, Lot Number: 22JBL421,22JBK767,22JBE516,22IBI257,22HBR344;
xxxxxxxx. EAR, Item Number: DYNJ909049, Case UDI/GTIN: 40195327257782, Unit UDI/GTIN: 10195327257781, Lot Number: 22JBR831,22JBE934;
yyyyyyyy. ENT I-LF, Item Number: DYNJS0702, Case UDI/GTIN: 40080196798729, Unit UDI/GTIN: 10080196798728, Lot Number: 22JBH268,22IBN852,22IBF769;
zzzzzzzz. ENT II-LF, Item Number: DYNJS0703, Case UDI/GTIN: 40080196597520, Unit UDI/GTIN: 10080196597529, Lot Number: 22JBJ174,22IBG858,22HBN515;
aaaaaaaaa. HEAD AND NECK PACK, Item Number: DYNJS3068, Case UDI/GTIN: 40888277058294, Unit UDI/GTIN: 10888277058293, Lot Number: 22JBH755,22HBQ646;
bbbbbbbbb. HEAD AND NECK PPH STD PACK-LF, Item Number: PHS184745F, Case UDI/GTIN: 40193489636681, Unit UDI/GTIN: 10193489636680, Lot Number: 22HBV665;
ccccccccc. ENT PACK-LF, Item Number: PHS408470C, Case UDI/GTIN: 40195327126330, Unit UDI/GTIN: 10195327126339, Lot Number: 22HBF930;
ddddddddd. ENT PACK-LF, Item Number: PHS408470D, Case UDI/GTIN: 40195327250639, Unit UDI/GTIN: 10195327250638, Lot Number: 22IBQ906 |
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 | 9,079 cases (27,563 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 |
|---|
|
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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