| |
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-1092-2023 |
| Recall Event ID |
91386 |
| Product Classification |
Cesarean section tray - Product Code OHM
|
| Product |
Sterile Procedural Trays, labeled as the following:
a. C-SECTION OR 30 CDS
b. C-SECTION CDS
c. C-SECTION CDS
d. C-SECTION CDS
e. MAJOR ORTHO CDS-LF
f. C-SECTION CDS
g. C-SECTION CDS
h. C-SECTION PROCEDURE
i. C-SECTION CDS-LF
j. C-SECTION CDS
k. C-SECTION CDS
l. C-SECTION
m. C-SECTION CDS
n. C-SECTION PACK-LF
o. C-SECTION PACK-LF
p. C-SECTION PACK-LF
q. C-SECTION PACK-LF
r. C-BIRTH PACK-LF
s. C SECTION PACK-LF
t. C-SECTION PACK-LF
u. C SECTION PACK-LF
v. C-SECTION PACK-LF
w. C SECTION PACK-LF
x. C-SECTION PACK-LF
y. C-SECTION PACK
z. C-SECTION PACK-LF
aa. C-SECTION PACK-LF
bb. C-SECTION PACK-LF
cc. C-SECTION PACK-LF
dd. C-BIRTH SETUP PACK-LF
ee. C-SECTION PACK-LF
ff. C-SECTION PACK-LF
gg. C-SECTION PACK-LF
hh. C SECTION PACK-LF
ii. C-SECTION PACK-LF
jj. C-SECTION TRAY
kk. C-SECTION PACK
ll. C-SECTION PACK-LF
mm. C-SECTION PACK
nn. C-SECTION PACK
oo. C-SECTION
pp. C-SECTION PACK
qq. SVMMC C-SECTION PACK
rr. C-SECTION PACK-LF
ss. C-SECTION SETUP PACK
tt. C-SECTION PACK
uu. C-SECTION PACK
vv. C-SECTION PACK *STANDARD*
ww. C-SECTION PACK
xx. C-SECTION PACK
yy. C-SECTION PACK
zz. C-SECTION 83305, MERCY REG
aaa. CUH C-SECTION PACK-LF
bbb. C-SECTION PACK-LF
ccc. C-SECTION PACK
ddd. C-SECTION PACK
eee. C-SECTION PACK
fff. C-SECTION PK
ggg. C-SECTION
hhh. C-SECTION PACK
iii. ST JO WEST C-SECTION BASIN-LF
jjj. C SECTION PACK
kkk. C-SECTION PACK
lll. C SECTION PACK
mmm. C SECTION DELIVERY
nnn. C-SECTION PACK
ooo. C-SECTION PACK
ppp. C SECTION
qqq. WR C SECTION PACK-LF
rrr. C-SECTION PACK
sss. PK, L&D-C SECTION
ttt. C-SECTION PACK HIGHLAND-LF
uuu. C- SECTION
vvv. C SECTION PACK-LF
www. C-SECTION PACK
xxx. C-SECTION PACK
yyy. C SECTION PACK
zzz. PK, L&D-C SECTION
aaaa. C SECTION PACK
bbbb. C SECTION PACK
cccc. C-SECTION PACK
dddd. SECTION PACK (CSSJE)642-LF
eeee. C-SECTION PACK
ffff. C-SECTION PACK-RFD
gggg. C-SECTION DELIVERY PACK-LF
hhhh. C-SECTION PACK
iiii. C SECTION PACK
jjjj. C-SECTION PACK
kkkk. C SECTION
llll. C SECTION PLUS PACK
mmmm. C SECTION PACK-6220
nnnn. C-SECTION PACK
oooo. C-SECTION PACK
pppp. C-SECTION PACK - WCH
qqqq. C SECTION WITH BASIN PACK
rrrr. PHP C-SECTION PACK-LF
ssss. C-SECTION KIT
tttt. C SECTION PACK
uuuu. C-SECTION
vvvv. C-SECTION I PACK-LF
wwww. C-SECTION PACK 2
xxxx. C-SECTION PACK-LF
yyyy. C-SECTION PACK
zzzz. C-SECTION PACK
aaaaa. C SECTION PACK
bbbbb. C-SECTION PACK
ccccc. C SECTION
ddddd. C SECTION PACK-LF
eeeee. C SECTION PACK-LF
fffff. BSMI CSECTION BIRTHING PACK
ggggg. C-SECTION PACK
hhhhh. C SECTION PACK-LF
iiiii. C-SECTION PACK
jjjjj. C SECTION PACK
kkkkk. C SECTION
lllll. PK, L&D-C SECTION
mmmmm. C-SECTION PACK
nnnnn. C SECTION
ooooo. C-SECTION PACK
ppppp. C-SECTION SMMC
qqqqq. C SECTION PACK
rrrrr. C SECTION PACK
sssss. C-SECTION PACK
ttttt. C SECTION #2 SHARED
uuuuu. C SECTION #3 SHARED
vvvvv. C SECTION
wwwww. C-SECTION PACK
xxxxx. CESAREAN BIRTH PACK
yyyyy. C SECTION PACK-LF
zzzzz. C-SECTION PACK
aaaaaa. C-SECTION PACK-LF
bbbbbb. C SECTION PACK
cccccc. C-SECTION PACK
dddddd. C-SECTION
eeeeee. C-SECTION
ffffff. C SECTION
gggggg. C-SECTION
hhhhhh. C SECTION
iiiiii. C-SECTION
jjjjjj. C-SECTION
kkkkkk. PROHEALTH C-SECTION
llllll. C SECTION
mmmmmm. C SECTION
nnnnnn. C-SECTION
oooooo. C-SECTION
pppppp. C-SECTION PACK
qqqqqq. C SECTION
rrrrrr. C SECTION
ssssss. C-SECTION
tttttt. C SECTION
uuuuuu. C-SECTION - SMH
vvvvvv. C-SECTION MRMC
wwwwww. SCHED C SECTION
xxxxxx. C-SECTION
yyyyyy. C-SECTION -LF
zzzzzz. ADVENTIST C-SECTION PACK
aaaaaaa. C-SECTION PK-LF
bbbbbbb. C-SECTION PROCEDURE
ccccccc. C-SECTION II-LF
ddddddd. C-SECTION I-LF
eeeeeee. C-SECTION PACK
fffffff. C-BIRTH PACK-LF
ggggggg. C-SECTION PACK
hhhhhhh. THEDACARE C-SECTION
iiiiiii. C-SECTION BASIN PACK
jjjjjjj. C-SECTION PACK
kkkkkkk. C-SECTION PACK-LF
lllllll. PPH C-SECTION PACK-LF
mmmmmmm. C SECTION PACK-LF
nnnnnnn. C-SECTION PACK
ooooooo. C-SECTION PACK-LF |
| Code Information |
a. C-SECTION OR 30 CDS, Item Number: CDS820075W, Case UDI/GTIN: 40195327209798, Unit UDI/GTIN: 10195327209797, Lot Number: 22JBX603,22JBX483;
b. C-SECTION CDS, Item Number: CDS830218J, Case UDI/GTIN: 40888277530172, Unit UDI/GTIN: 10888277530171, Lot Number: 22JBV584;
c. C-SECTION CDS, Item Number: CDS980747J, Case UDI/GTIN: 40193489923613, Unit UDI/GTIN: 10193489923612, Lot Number: 22JBO006;
d. C-SECTION CDS, Item Number: CDS981430C, Case UDI/GTIN: 40193489260879, Unit UDI/GTIN: 10193489260878, Lot Number: 22JMG179;
e. MAJOR ORTHO CDS-LF, Item Number: CDS982233G, Case UDI/GTIN: 40193489986212, Unit UDI/GTIN: 10193489986211, Lot Number: 22JMG573;
f. C-SECTION CDS, Item Number: CDS982367I, Case UDI/GTIN: 40193489312349, Unit UDI/GTIN: 10193489312348, Lot Number: 22KBE753,22KBC690;
g. C-SECTION CDS, Item Number: CDS983117G, Case UDI/GTIN: 40195327192113, Unit UDI/GTIN: 10195327192112, Lot Number: 22IBR943;
h. C-SECTION PROCEDURE, Item Number: CDS983450L, Case UDI/GTIN: 40193489372336, Unit UDI/GTIN: 10193489372335, Lot Number: 22KBE444,22IBD865,22IBE112;
i. C-SECTION CDS-LF, Item Number: CDS983869I, Case UDI/GTIN: 40888277752734, Unit UDI/GTIN: 10888277752733, Lot Number: 22JDB259;
j. C-SECTION CDS, Item Number: CDS983917M, Case UDI/GTIN: 40193489402712, Unit UDI/GTIN: 10193489402711, Lot Number: 22JBO248;
k. C-SECTION CDS, Item Number: CDS984354C, Case UDI/GTIN: 40193489738187, Unit UDI/GTIN: 10193489738186, Lot Number: 22JBC335;
l. C-SECTION, Item Number: CDS984902K, Case UDI/GTIN: 40195327156924, Unit UDI/GTIN: 10195327156923, Lot Number: 22IBQ711,22IBL648;
m. C-SECTION CDS, Item Number: CDS985206B, Case UDI/GTIN: 40889942942078, Unit UDI/GTIN: 10889942942077, Lot Number: 22JBL398;
n. C-SECTION PACK-LF, Item Number: DYNJ0173422AF, Case UDI/GTIN: 40195327097579, Unit UDI/GTIN: 10195327097578, Lot Number: 22JMA807;
o. C-SECTION PACK-LF, Item Number: DYNJ0188507C, Case UDI/GTIN: 40889942053491, Unit UDI/GTIN: 10889942053490, Lot Number: 22JBY657,22IBI286;
p. C-SECTION PACK-LF, Item Number: DYNJ0200274P, Case UDI/GTIN: 40889942054115, Unit UDI/GTIN: 10889942054114, Lot Number: 22IMG322;
q. C-SECTION PACK-LF, Item Number: DYNJ0365888N, Case UDI/GTIN: 40195327045273, Unit UDI/GTIN: 10195327045272, Lot Number: 22IMF444,22HMF014;
r. C-BIRTH PACK-LF, Item Number: DYNJ0366291M, Case UDI/GTIN: 40889942059615, Unit UDI/GTIN: 10889942059614, Lot Number: 22IME718;
s. C SECTION PACK-LF, Item Number: DYNJ0367189M, Case UDI/GTIN: 40193489788298, Unit UDI/GTIN: 10193489788297, Lot Number: 22IMG638,22HMC273;
t. C-SECTION PACK-LF, Item Number: DYNJ0367679W, Case UDI/GTIN: 40193489617369, Unit UDI/GTIN: 10193489617368, Lot Number: 22JMI197,22IMD016;
u. C SECTION PACK-LF, Item Number: DYNJ0376534Q, Case UDI/GTIN: 40195327237173, Unit UDI/GTIN: 10195327237172, Lot Number: 22IBE468;
v. C-SECTION PACK-LF, Item Number: DYNJ0382235G, Case UDI/GTIN: 40889942435020, Unit UDI/GTIN: 10889942435029, Lot Number: 22IBC549,22IBC247,22HBG107;
w. C SECTION PACK-LF, Item Number: DYNJ0397841N, Case UDI/GTIN: 40193489824064, Unit UDI/GTIN: 10193489824063, Lot Number: 22IBL780;
x. C-SECTION PACK-LF, Item Number: DYNJ04609I, Case UDI/GTIN: 40193489552707, Unit UDI/GTIN: 10193489552706, Lot Number: 22IMA202;
y. C-SECTION PACK, Item Number: DYNJ04620S, Case UDI/GTIN: 40195327135851, Unit UDI/GTIN: 10195327135850, Lot Number: 22IMB266;
z. C-SECTION PACK-LF, Item Number: DYNJ04724Q, Case UDI/GTIN: 40193489554015, Unit UDI/GTIN: 10193489554014, Lot Number: 22IMF982;
aa. C-SECTION PACK-LF, Item Number: DYNJ0508830M, Case UDI/GTIN: 40193489579247, Unit UDI/GTIN: 10193489579246, Lot Number: 22IMD130;
bb. C-SECTION PACK-LF, Item Number: DYNJ0551773O, Case UDI/GTIN: 40193489268622, Unit UDI/GTIN: 10193489268621, Lot Number: 22JBS505;
cc. C-SECTION PACK-LF, Item Number: DYNJ06584K, Case UDI/GTIN: 40193489420525, Unit UDI/GTIN: 10193489420524, Lot Number: 22JBY658,22IBU471,22HBL261;
dd. C-BIRTH SETUP PACK-LF, Item Number: DYNJ0781722T, Case UDI/GTIN: 40193489226356, Unit UDI/GTIN: 10193489226355, Lot Number: 22JMG062;
ee. C-SECTION PACK-LF, Item Number: DYNJ07836Q, Case UDI/GTIN: 40195327209552, Unit UDI/GTIN: 10195327209551, Lot Number: 22IBO410;
ff. C-SECTION PACK-LF, Item Number: DYNJ0842739K, Case UDI/GTIN: 40193489359634, Unit UDI/GTIN: 10193489359633, Lot Number: 22JDB302;
gg. C-SECTION PACK-LF, Item Number: DYNJ0843654G, Case UDI/GTIN: 40889942402855, Unit UDI/GTIN: 10889942402854, Lot Number: 22IDB683,22IDA305;
hh. C SECTION PACK-LF, Item Number: DYNJ0923021, Case UDI/GTIN: 40889942099642, Unit UDI/GTIN: 10889942099641, Lot Number: 22JMH549,22IMF460;
ii. C-SECTION PACK-LF, Item Number: DYNJ15232M, Case UDI/GTIN: 40195327231744, Unit UDI/GTIN: 10195327231743, Lot Number: 22IMH405;
jj. C-SECTION TRAY, Item Number: DYNJ15494G, Case UDI/GTIN: 40193489961196, Unit UDI/GTIN: 10193489961195, Lot Number: 22IBI076;
kk. C-SECTION PACK, Item Number: DYNJ15726I, Case UDI/GTIN: 40193489832403, Unit UDI/GTIN: 10193489832402, Lot Number: 22JBU168;
ll. C-SECTION PACK-LF, Item Number: DYNJ16672I, Case UDI/GTIN: 40193489990752, Unit UDI/GTIN: 10193489990751, Lot Number: 22JBK965,22IBL997,22HBU474,22HBV462;
mm. C-SECTION PACK, Item Number: DYNJ19958P, Case UDI/GTIN: 40193489867733, Unit UDI/GTIN: 10193489867732, Lot Number: 22JMI344,22IMG005,22HME230;
nn. C-SECTION PACK, Item Number: DYNJ20135M, Case UDI/GTIN: 40193489905534, Unit UDI/GTIN: 10193489905533, Lot Number: 22JBS400;
oo. C-SECTION, Item Number: DYNJ22368I, Case UDI/GTIN: 40193489780513, Unit UDI/GTIN: 10193489780512, Lot Number: 22IBN332;
pp. C-SECTION PACK, Item Number: DYNJ24120C, Case UDI/GTIN: 40884389396507, Unit UDI/GTIN: 10884389396506, Lot Number: 22IBF425;
qq. SVMMC C-SECTION PACK, Item Number: DYNJ24632K, Case UDI/GTIN: 40195327058624, Unit UDI/GTIN: 10195327058623, Lot Number: 22JLB138,22ILA591;
rr. C-SECTION PACK-LF, Item Number: DYNJ26665J, Case UDI/GTIN: 40889942112136, Unit UDI/GTIN: 10889942112135, Lot Number: 22JBW002;
ss. C-SECTION SETUP PACK, Item Number: DYNJ27751F, Case UDI/GTIN: 40195327228706, Unit UDI/GTIN: 10195327228705, Lot Number: 22JDA003,22HDC395,22HDA918;
tt. C-SECTION PACK, Item Number: DYNJ29034F, Case UDI/GTIN: 40193489461146, Unit UDI/GTIN: 10193489461145, Lot Number: 22IME948;
uu. C-SECTION PACK, Item Number: DYNJ30483F, Case UDI/GTIN: 40193489912419, Unit UDI/GTIN: 10193489912418, Lot Number: 22JMB299,22HMB825;
vv. C-SECTION PACK *STANDARD*, Item Number: DYNJ30609G, Case UDI/GTIN: 40193489301541, Unit UDI/GTIN: 10193489301540, Lot Number: 22IMG006;
ww. C-SECTION PACK, Item Number: DYNJ30610D, Case UDI/GTIN: 40889942491972, Unit UDI/GTIN: 10889942491971, Lot Number: 22HDC051;
xx. C-SECTION PACK, Item Number: DYNJ31011D, Case UDI/GTIN: 40889942383413, Unit UDI/GTIN: 10889942383412, Lot Number: 22JBR171;
yy. C-SECTION PACK, Item Number: DYNJ32011G, Case UDI/GTIN: 40195327067046, Unit UDI/GTIN: 10195327067045, Lot Number: 22JMH079;
zz. C-SECTION 83305, MERCY REG, Item Number: DYNJ32059F, Case UDI/GTIN: 40193489822497, Unit UDI/GTIN: 10193489822496, Lot Number: 22IBV950;
aaa. CUH C-SECTION PACK-LF, Item Number: DYNJ32253G, Case UDI/GTIN: 40195327066537, Unit UDI/GTIN: 10195327066536, Lot Number: 22IBJ049;
bbb. C-SECTION PACK-LF, Item Number: DYNJ33059B, Case UDI/GTIN: 40193489950947, Unit UDI/GTIN: 10193489950946, Lot Number: 22JBO407,22IBG828,22HBR300;
ccc. C-SECTION PACK, Item Number: DYNJ33188B, Case UDI/GTIN: 40888277746283, Unit UDI/GTIN: 10888277746282, Lot Number: 22JMH212,22IMI213;
ddd. C-SECTION PACK, Item Number: DYNJ33550B, Case UDI/GTIN: 40889942435686, Unit UDI/GTIN: 10889942435685, Lot Number: 22JMF403;
eee. C-SECTION PACK, Item Number: DYNJ33799C, Case UDI/GTIN: 40889942447153, Unit UDI/GTIN: 10889942447152, Lot Number: 22JBI238,22HBG189;
fff. C-SECTION PK, Item Number: DYNJ34266B, Case UDI/GTIN: 40888277246516, Unit UDI/GTIN: 10888277246515, Lot Number: 22IBK679;
ggg. C-SECTION, Item Number: DYNJ34431G, Case UDI/GTIN: 40193489834957, Unit UDI/GTIN: 10193489834956, Lot Number: 22JBN841;
hhh. C-SECTION PACK, Item Number: DYNJ36310K, Case UDI/GTIN: 40193489443456, Unit UDI/GTIN: 10193489443455, Lot Number: 22JMG326;
iii. ST JO WEST C-SECTION BASIN-LF, Item Number: DYNJ37027A, Case UDI/GTIN: 40889942418320, Unit UDI/GTIN: 10889942418329, Lot Number: 22JBR330,22HBT598;
jjj. C SECTION PACK, Item Number: DYNJ37622C, Case UDI/GTIN: 40884389864235, Unit UDI/GTIN: 10884389864234, Lot Number: 22IBT225;
kkk. C-SECTION PACK, Item Number: DYNJ38350J, Case UDI/GTIN: 40195327129959, Unit UDI/GTIN: 10195327129958, Lot Number: 22JMC173,22IME739,22HMD564;
lll. C SECTION PACK, Item Number: DYNJ38440C, Case UDI/GTIN: 40195327061792, Unit UDI/GTIN: 10195327061791, Lot Number: 22JMC367,22IMF067;
mmm. C SECTION DELIVERY, Item Number: DYNJ39375F, Case UDI/GTIN: 40193489418980, Unit UDI/GTIN: 10193489418989, Lot Number: 22IBG340;
nnn. C-SECTION PACK, Item Number: DYNJ40458B, Case UDI/GTIN: 40889942109334, Unit UDI/GTIN: 10889942109333, Lot Number: 22IBS430,22HBH047;
ooo. C-SECTION PACK, Item Number: DYNJ40503B, Case UDI/GTIN: 40193489614931, Unit UDI/GTIN: 10193489614930, Lot Number: 22IDB276;
ppp. C SECTION, Item Number: DYNJ41268B, Case UDI/GTIN: 40193489487627, Unit UDI/GTIN: 10193489487626, Lot Number: 22IMF995,22IMF998;
qqq. WR C SECTION PACK-LF, Item Number: DYNJ41570K, Case UDI/GTIN: 40195327089772, Unit UDI/GTIN: 10195327089771, Lot Number: 22IMF970,22IMG359;
rrr. C-SECTION PACK, Item Number: DYNJ42226D, Case UDI/GTIN: 40195327017935, Unit UDI/GTIN: 10195327017934, Lot Number: 22IMG051,22IMG068;
sss. PK, L&D-C SECTION, Item Number: DYNJ42476I, Case UDI/GTIN: 40193489266017, Unit UDI/GTIN: 10193489266016, Lot Number: 22JBU242;
ttt. C-SECTION PACK HIGHLAND-LF, Item Number: DYNJ42634B, Case UDI/GTIN: 40888277582805, Unit UDI/GTIN: 10888277582804, Lot Number: 22IBD370;
uuu. C- SECTION, Item Number: DYNJ42651, Case UDI/GTIN: 40888277003584, Unit UDI/GTIN: 10888277003583, Lot Number: 22IME346,22IME347,22HMC131;
vvv. C SECTION PACK-LF, Item Number: DYNJ42850A, Case UDI/GTIN: 40193489880909, Unit UDI/GTIN: 10193489880908, Lot Number: 22JBN852;
www. C-SECTION PACK, Item Number: DYNJ42946A, Case UDI/GTIN: 40195327196838, Unit UDI/GTIN: 10195327196837, Lot Number: 22IBV689,22HBH787;
xxx. C-SECTION PACK, Item Number: DYNJ43284D, Case UDI/GTIN: 40888277984128, Unit UDI/GTIN: 10888277984127, Lot Number: 22IMG361;
yyy. C SECTION PACK, Item Number: DYNJ43732F, Case UDI/GTIN: 40193489549370, Unit UDI/GTIN: 10193489549379, Lot Number: 22IBI952;
zzz. PK, L&D-C SECTION, Item Number: DYNJ43746C, Case UDI/GTIN: 40193489310635, Unit UDI/GTIN: 10193489310634, Lot Number: 22JBO122;
aaaa. C SECTION PACK, Item Number: DYNJ43810A, Case UDI/GTIN: 40193489298056, Unit UDI/GTIN: 10193489298055, Lot Number: 22IBK239;
bbbb. C SECTION PACK, Item Number: DYNJ46508F, Case UDI/GTIN: 40195327111787, Unit UDI/GTIN: 10195327111786, Lot Number: 22JME929;
cccc. C-SECTION PACK, Item Number: DYNJ47220C, Case UDI/GTIN: 40889942131359, Unit UDI/GTIN: 10889942131358, Lot Number: 22JMD043;
dddd. SECTION PACK (CSSJE)642-LF, Item Number: DYNJ47485C, Case UDI/GTIN: 40193489586597, Unit UDI/GTIN: 10193489586596, Lot Number: 22IMI230;
eeee. C-SECTION PACK, Item Number: DYNJ47606B, Case UDI/GTIN: 40193489730693, Unit UDI/GTIN: 10193489730692, Lot Number: 22IBV197;
ffff. C-SECTION PACK-RFD, Item Number: DYNJ47761K, Case UDI/GTIN: 40193489896986, Unit UDI/GTIN: 10193489896985, Lot Number: 22IME390;
gggg. C-SECTION DELIVERY PACK-LF, Item Number: DYNJ47808F, Case UDI/GTIN: 40195327232604, Unit UDI/GTIN: 10195327232603, Lot Number: 22IMB729;
hhhh. C-SECTION PACK, Item Number: DYNJ48272, Case UDI/GTIN: 40888277575371, Unit UDI/GTIN: 10888277575370, Lot Number: 22IBO504,22HMD672;
iiii. C SECTION PACK, Item Number: DYNJ48483D, Case UDI/GTIN: 40195327030811, Unit UDI/GTIN: 10195327030810, Lot Number: 22JMI251;
jjjj. C-SECTION PACK, Item Number: DYNJ48746A, Case UDI/GTIN: 40889942385691, Unit UDI/GTIN: 10889942385690, Lot Number: 22JMA582;
kkkk. C SECTION, Item Number: DYNJ49172G, Case UDI/GTIN: 40193489308243, Unit UDI/GTIN: 10193489308242, Lot Number: 22IMC797,22HME909;
llll. C SECTION PLUS PACK, Item Number: DYNJ49370D, Case UDI/GTIN: 40193489213318, Unit UDI/GTIN: 10193489213317, Lot Number: 22JBO103,22HBR997,22HBG119;
mmmm. C SECTION PACK-6220, Item Number: DYNJ49519A, Case UDI/GTIN: 40889942024835, Unit UDI/GTIN: 10889942024834, Lot Number: 22IBN420;
nnnn. C-SECTION PACK, Item Number: DYNJ49668A, Case UDI/GTIN: 40889942390176, Unit UDI/GTIN: 10889942390175, Lot Number: 22JBS277,22IBR285;
oooo. C-SECTION PACK, Item Number: DYNJ49771, Case UDI/GTIN: 40888277881144, Unit UDI/GTIN: 10888277881143, Lot Number: 22IBQ282;
pppp. C-SECTION PACK - WCH, Item Number: DYNJ49829F, Case UDI/GTIN: 40193489631570, Unit UDI/GTIN: 10193489631579, Lot Number: 22JBX669;
qqqq. C SECTION WITH BASIN PACK, Item Number: DYNJ51378G, Case UDI/GTIN: 40193489996389, Unit UDI/GTIN: 10193489996388, Lot Number: 22IBN196;
rrrr. PHP C-SECTION PACK-LF, Item Number: DYNJ51603D, Case UDI/GTIN: 40195327167050, Unit UDI/GTIN: 10195327167059, Lot Number: 22JMG359,22IMA243;
ssss. C-SECTION KIT, Item Number: DYNJ51655C, Case UDI/GTIN: 40195327187850, Unit UDI/GTIN: 10195327187859, Lot Number: 22IME130;
tttt. C SECTION PACK, Item Number: DYNJ51872D, Case UDI/GTIN: 40195327043439, Unit UDI/GTIN: 10195327043438, Lot Number: 22JBI664;
uuuu. C-SECTION, Item Number: DYNJ51997, Case UDI/GTIN: 40889942233107, Unit UDI/GTIN: 10889942233106, Lot Number: 22JBP756,22IBR427;
vvvv. C-SECTION I PACK-LF, Item Number: DYNJ52040F, Case UDI/GTIN: 40195327096145, Unit UDI/GTIN: 10195327096144, Lot Number: 22JBO202,22JBN048,22HBG758;
wwww. C-SECTION PACK 2, Item Number: DYNJ52168A, Case UDI/GTIN: 40193489539739, Unit UDI/GTIN: 10193489539738, Lot Number: 22JBD226,22IBP554,22IBM605;
xxxx. C-SECTION PACK-LF, Item Number: DYNJ52908A, Case UDI/GTIN: 40889942851981, Unit UDI/GTIN: 10889942851980, Lot Number: 22IMC339,22HMC091;
yyyy. C-SECTION PACK, Item Number: DYNJ52931D, Case UDI/GTIN: 40195327200221, Unit UDI/GTIN: 10195327200220, Lot Number: 22IBR773;
zzzz. C-SECTION PACK, Item Number: DYNJ53386C, Case UDI/GTIN: 40195327169696, Unit UDI/GTIN: 10195327169695, Lot Number: 22JMF746;
aaaaa. C SECTION PACK, Item Number: DYNJ53399I, Case UDI/GTIN: 40193489968478, Unit UDI/GTIN: 10193489968477, Lot Number: 22JMF705;
bbbbb. C-SECTION PACK, Item Number: DYNJ53598F, Case UDI/GTIN: 40195327055821, Unit UDI/GTIN: 10195327055820, Lot Number: 22IMB353,22IMB057;
ccccc. C SECTION, Item Number: DYNJ53654F, Case UDI/GTIN: 40193489454674, Unit UDI/GTIN: 10193489454673, Lot Number: 22IBI089;
ddddd. C SECTION PACK-LF, Item Number: DYNJ54186A, Case UDI/GTIN: 40195327062607, Unit UDI/GTIN: 10195327062606, Lot Number: 22JMF820;
eeeee. C SECTION PACK-LF, Item Number: DYNJ54374J, Case UDI/GTIN: 40193489404075, Unit UDI/GTIN: 10193489404074, Lot Number: 22IBM226;
fffff. BSMI CSECTION BIRTHING PACK, Item Number: DYNJ54946G, Case UDI/GTIN: 40195327135455, Unit UDI/GTIN: 10195327135454, Lot Number: 22IBJ472,22HBA609;
ggggg. C-SECTION PACK, Item Number: DYNJ55336A, Case UDI/GTIN: 40889942781097, Unit UDI/GTIN: 10889942781096, Lot Number: 22KBB430;
hhhhh. C SECTION PACK-LF, Item Number: DYNJ55466C, Case UDI/GTIN: 40193489408158, Unit UDI/GTIN: 10193489408157, Lot Number: 22IBN820,22HBW539;
iiiii. C-SECTION PACK, Item Number: DYNJ55719, Case UDI/GTIN: 40889942574590, Unit UDI/GTIN: 10889942574599, Lot Number: 22IBR318;
jjjjj. C SECTION PACK, Item Number: DYNJ57193A, Case UDI/GTIN: 40193489647656, Unit UDI/GTIN: 10193489647655, Lot Number: 22IBF463;
kkkkk. C SECTION, Item Number: DYNJ57622, Case UDI/GTIN: 40889942757245, Unit UDI/GTIN: 10889942757244, Lot Number: 22IBF901;
lllll. PK, L&D-C SECTION, Item Number: DYNJ58239B, Case UDI/GTIN: 40195327248766, Unit UDI/GTIN: 10195327248765, Lot Number: 22IMH256,22IMH497;
mmmmm. C-SECTION PACK, Item Number: DYNJ58493A, Case UDI/GTIN: 40193489517423, Unit UDI/GTIN: 10193489517422, Lot Number: 22JBU325;
nnnnn. C SECTION, Item Number: DYNJ58551, Case UDI/GTIN: 40889942870982, Unit UDI/GTIN: 10889942870981, Lot Number: 22JBO158;
ooooo. C-SECTION PACK, Item Number: DYNJ59414A, Case UDI/GTIN: 40195327066452, Unit UDI/GTIN: 10195327066451, Lot Number: 22JMF097;
ppppp. C-SECTION SMMC, Item Number: DYNJ59457A, Case UDI/GTIN: 40195327243266, Unit UDI/GTIN: 10195327243265, Lot Number: 22JMD987;
qqqqq. C SECTION PACK, Item Number: DYNJ61573, Case UDI/GTIN: 40193489601078, Unit UDI/GTIN: 10193489601077, Lot Number: 22JMA868,22IMF177;
rrrrr. C SECTION PACK, Item Number: DYNJ64493A, Case UDI/GTIN: 40193489323260, Unit UDI/GTIN: 10193489323269, Lot Number: 22IBI098;
sssss. C-SECTION PACK, Item Number: DYNJ64678A, Case UDI/GTIN: 40195327225996, Unit UDI/GTIN: 10195327225995, Lot Number: 22JDB087;
ttttt. C SECTION #2 SHARED, Item Number: DYNJ64773C, Case UDI/GTIN: 40195327221066, Unit UDI/GTIN: 10195327221065, Lot Number: 22IDA431;
uuuuu. C SECTION #3 SHARED, Item Number: DYNJ64774D, Case UDI/GTIN: 40195327233885, Unit UDI/GTIN: 10195327233884, Lot Number: 22IDC063,22IDA788;
vvvvv. C SECTION, Item Number: DYNJ65646B, Case UDI/GTIN: 40195327146789, Unit UDI/GTIN: 10195327146788, Lot Number: 22IBF374;
wwwww. C-SECTION PACK, Item Number: DYNJ65961B, Case UDI/GTIN: 40193489984300, Unit UDI/GTIN: 10193489984309, Lot Number: 22IME243;
xxxxx. CESAREAN BIRTH PACK, Item Number: DYNJ67620, Case UDI/GTIN: 40193489418164, Unit UDI/GTIN: 10193489418163, Lot Number: 22JBX125,22HBR751,22HBS988;
yyyyy. C SECTION PACK-LF, Item Number: DYNJ67957, Case UDI/GTIN: 40193489458979, Unit UDI/GTIN: 10193489458978, Lot Number: 22JMH427,22JMD099,22IMH525;
zzzzz. C-SECTION PACK, Item Number: DYNJ68954, Case UDI/GTIN: 40193489863469, Unit UDI/GTIN: 10193489863468, Lot Number: 22JMF850;
aaaaaa. C-SECTION PACK-LF, Item Number: DYNJ69445, Case UDI/GTIN: 40193489942515, Unit UDI/GTIN: 10193489942514, Lot Number: 22JBR185,22IBG076;
bbbbbb. C SECTION PACK, Item Number: DYNJ82554, Case UDI/GTIN: 40195327198245, Unit UDI/GTIN: 10195327198244, Lot Number: 22JBQ815;
cccccc. C-SECTION PACK, Item Number: DYNJ83021, Case UDI/GTIN: 40195327228911, Unit UDI/GTIN: 10195327228910, Lot Number: 22JBN586;
dddddd. C-SECTION, Item Number: DYNJ900260A, Case UDI/GTIN: 40195327178537, Unit UDI/GTIN: 10195327178536, Lot Number: 22IBQ946;
eeeeee. C-SECTION, Item Number: DYNJ900266C, Case UDI/GTIN: 40193489278430, Unit UDI/GTIN: 10193489278439, Lot Number: 22IBS357;
ffffff. C SECTION, Item Number: DYNJ900794, Case UDI/GTIN: 40888277906601, Unit UDI/GTIN: 10888277906600, Lot Number: 22KBF556,22JBM372,22IBI225;
gggggg. C-SECTION, Item Number: DYNJ902761D, Case UDI/GTIN: 40193489891059, Unit UDI/GTIN: 10193489891058, Lot Number: 22JMG886,22JMD346;
hhhhhh. C SECTION, Item Number: DYNJ903771B, Case UDI/GTIN: 40193489935968, Unit UDI/GTIN: 10193489935967, Lot Number: 22JBN602,22JBN603,22HBX117;
iiiiii. C-SECTION, Item Number: DYNJ904357D, Case UDI/GTIN: 40195327223091, Unit UDI/GTIN: 10195327223090, Lot Number: 22JBE816,22IBR279;
jjjjjj. C-SECTION, Item Number: DYNJ904612F, Case UDI/GTIN: 40193489844048, Unit UDI/GTIN: 10193489844047, Lot Number: 22JBA083;
kkkkkk. PROHEALTH C-SECTION, Item Number: DYNJ904879D, Case UDI/GTIN: 40193489400107, Unit UDI/GTIN: 10193489400106, Lot Number: 22KBC325;
llllll. C SECTION, Item Number: DYNJ905314G, Case UDI/GTIN: 40193489930536, Unit UDI/GTIN: 10193489930535, Lot Number: 22JBR953;
mmmmmm. C SECTION, Item Number: DYNJ905776C, Case UDI/GTIN: 40195327179862, Unit UDI/GTIN: 10195327179861, Lot Number: 22KBF490;
nnnnnn. C-SECTION, Item Number: DYNJ905792C, Case UDI/GTIN: 40195327108428, Unit UDI/GTIN: 10195327108427, Lot Number: 22IMF389;
oooooo. C-SECTION, Item Number: DYNJ906470D, Case UDI/GTIN: 40195327204243, Unit UDI/GTIN: 10195327204242, Lot Number: 22IDC048;
pppppp. C-SECTION PACK, Item Number: DYNJ906557A, Case UDI/GTIN: 40193489436373, Unit UDI/GTIN: 10193489436372, Lot Number: 22IBT728;
qqqqqq. C SECTION, Item Number: DYNJ906917A, Case UDI/GTIN: 40193489460378, Unit UDI/GTIN: 10193489460377, Lot Number: 22JBJ828;
rrrrrr. C SECTION, Item Number: DYNJ907073, Case UDI/GTIN: 40193489337069, Unit UDI/GTIN: 10193489337068, Lot Number: 22IBE728;
ssssss. C-SECTION, Item Number: DYNJ907228F, Case UDI/GTIN: 40195327247448, Unit UDI/GTIN: 10195327247447, Lot Number: 22JBC329;
tttttt. C SECTION, Item Number: DYNJ907660A, Case UDI/GTIN: 40195327168668, Unit UDI/GTIN: 10195327168667, Lot Number: 22IMG417;
uuuuuu. C-SECTION - SMH, Item Number: DYNJ907724A, Case UDI/GTIN: 40193489976381, Unit UDI/GTIN: 10193489976380, Lot Number: 22JBH655,22IBA564;
vvvvvv. C-SECTION MRMC, Item Number: DYNJ907745B, Case UDI/GTIN: 40195327195411, Unit UDI/GTIN: 10195327195410, Lot Number: 22KBE700,22IBE731,22HBU387;
wwwwww. SCHED C SECTION, Item Number: DYNJ907956, Case UDI/GTIN: 40193489949439, Unit UDI/GTIN: 10193489949438, Lot Number: 22IBQ951;
xxxxxx. C-SECTION, Item Number: DYNJ908197, Case UDI/GTIN: 40195327006502, Unit UDI/GTIN: 10195327006501, Lot Number: 22JDB121;
yyyyyy. C-SECTION -LF, Item Number: DYNJ9932207R, Case UDI/GTIN: 40193489624152, Unit UDI/GTIN: 10193489624151, Lot Number: 22JMD352;
zzzzzz. ADVENTIST C-SECTION PACK, Item Number: DYNJADV101A, Case UDI/GTIN: 40888277576170, Unit UDI/GTIN: 10888277576179, Lot Number: 22IBS980,22HBW715;
aaaaaaa. C-SECTION PK-LF, Item Number: DYNJC2363J, Case UDI/GTIN: 40195327131341, Unit UDI/GTIN: 10195327131340, Lot Number: 22HBI849,22HBI850;
bbbbbbb. C-SECTION PROCEDURE, Item Number: DYNJQ9038I, Case UDI/GTIN: 40889942629948, Unit UDI/GTIN: 10889942629947, Lot Number: 22HBR429;
ccccccc. C-SECTION II-LF, Item Number: DYNJS0612, Case UDI/GTIN: 40080196942504, Unit UDI/GTIN: 10080196942503, Lot Number: 22JBK525,22IBP836,22HBX278,22HBN836,22HBG183,22HBG185;
ddddddd. C-SECTION I-LF, Item Number: DYNJS3038, Case UDI/GTIN: 40884389450216, Unit UDI/GTIN: 10884389450215, Lot Number: 22JDA185,22HDC283,22HDB455,22HDA724;
eeeeeee. C-SECTION PACK, Item Number: DYNJT0473I, Case UDI/GTIN: 40889942954057, Unit UDI/GTIN: 10889942954056, Lot Number: 22IMH365;
fffffff. C-BIRTH PACK-LF, Item Number: DYNJT1915K, Case UDI/GTIN: 40193489899376, Unit UDI/GTIN: 10193489899375, Lot Number: 22IBN792,22IBE982;
ggggggg. C-SECTION PACK, Item Number: OBJ602U, Case UDI/GTIN: 40193489964470, Unit UDI/GTIN: 10193489964479, Lot Number: 22JBP919,22IBK343;
hhhhhhh. THEDACARE C-SECTION, Item Number: OBP112X, Case UDI/GTIN: 40195327147649, Unit UDI/GTIN: 10195327147648, Lot Number: 22HBB733;
iiiiiii. C-SECTION BASIN PACK, Item Number: OBP211C, Case UDI/GTIN: 40884389069746, Unit UDI/GTIN: 10884389069745, Lot Number: 22IBM827,22HBW292;
jjjjjjj. C-SECTION PACK, Item Number: OBP323G, Case UDI/GTIN: 40193489886413, Unit UDI/GTIN: 10193489886412, Lot Number: 22IBA633,22HBI799,22HBI800;
kkkkkkk. C-SECTION PACK-LF, Item Number: PHS164410001, Case UDI/GTIN: 40889942035749, Unit UDI/GTIN: 10889942035748, Lot Number: 22IMG290;
lllllll. PPH C-SECTION PACK-LF, Item Number: PHS322253008B, Case UDI/GTIN: 40193489636889, Unit UDI/GTIN: 10193489636888, Lot Number: 22IBN335;
mmmmmmm. C SECTION PACK-LF, Item Number: PHS410129014C, Case UDI/GTIN: 40889942936961, Unit UDI/GTIN: 10889942936960, Lot Number: 22JBC784;
nnnnnnn. C-SECTION PACK, Item Number: PHS774420G, Case UDI/GTIN: 40889942942511, Unit UDI/GTIN: 10889942942510, Lot Number: 22IMC958;
ooooooo. C-SECTION PACK-LF, Item Number: PHS988341C, Case UDI/GTIN: 40889942484820, Unit UDI/GTIN: 10889942484829, Lot Number: 22IMH544 |
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 |
11,886 cases (27,144 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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