| | 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-1091-2023 |
|---|
| Recall Event ID |
91386 |
| Product Classification |
Gynecological laparoscopic kit - Product Code OHD
|
| Product | Sterile Procedural Trays, labeled as the following:
a. GYN-URO LAPSCP CDS-LF
b. ROBOTIC CDS
c. GYN LAPAROSCOPY CDS-LF
d. GYN LAPAROSCOPY
e. GYN LAPAROSCOPY CDS
f. UNIVERSAL ROBOTIC ORLANDO
g. GYN ROBOTIC CDS
h. GYN LAPAROSCOPY CDS-1
i. CUH GYN LAPAROSCOPY CDS
j. CUH GEN/GYN ROBOTIC CDS
k. LAVH CDS-LF
l. GYN LAPAROSCOPY CDS-LF
m. GYN LAPAROSCOPY CDS UCC-LF
n. DAY SURG GYN LAP CDS
o. GYN LAPAROSCOPY CDS
p. DAVINCI HYSTERECTOMY CDS
q. GYN LAP/ROBOTIC
r. DAVINCI PACK-LF
s. DAVINCI PACK-LF
t. GYN LAPAROSCOPY PACK-LF
u. ROBOTIC PACK
v. GYN LAP - UNIV
w. BASIC LAVH PACK
x. GYN/LAPAROSCOPY PACK-LF
y. LAPAROSCOPIC GYN PACK-LF
z. DAVINCI PACK-LF
aa. SCC GYN LAPAROSCOPY PACK
bb. URO GYN PACK-LF
cc. GYN LAPAROSCOPY PACK
dd. TUBAL PACK
ee. GYN LAP PACK-LF
ff. LAVH PACK
gg. GYN LAPAROSCOPY-LF
hh. LAVH PACK
ii. PK-GYN-LAPAROSCOPY
jj. MAJOR LAP PACK 2-LF
kk. TUBAL PACK
ll. GYN LAPAROSCOPY PACK-LF
mm. PK, ROBOTICS-GYN
nn. SVMMC GEN ROBOTIC PACK
oo. SVMMC GYN ROBOTIC PACK
pp. PACK, GYN-D&C
qq. DA VINCI PROSTATE/COLPOPEXY
rr. ROBOT PACK
ss. PK, GYN-LAPAROSCOPY
tt. LAPAROSCOPIC GYN PACK
uu. DAVINCI PACK-RFD
vv. GYN ROBOTIC PACK
ww. LAVH PACK
xx. ST. ANNE'S MULTI PORT PACK
yy. LAVH PACK
zz. SOUTH SC RFT GYN LAP PACK
aaa. GYN LAPAROSCOPY PACK
bbb. LITHOTOMY PENILE PACK
ccc. DAVINCI GENERAL PACK
ddd. DAVINCI GYN PACK
eee. DAVINCI GYN PACK
fff. ROBOTIC PROSTATE PACK
ggg. GYN ROBOTIC PACK-LF
hhh. SCRIPPS SW ROBOTIC PACK
iii. GYN LITHOTOMY PACK
jjj. GYN LAPAROSCOPY PACK
kkk. DEACONESS PELVIC LAP PACK
lll. WOMENS ROBOT PACK
mmm. GYN LAPAROSCOPY PACK-LF
nnn. MAJOR GYN PACK
ooo. GYN LAPAROSCOPY PACK
ppp. TUBAL PACK-LF
qqq. PK, GYN-LAPAROSCOPY
rrr. LAVH PACK
sss. LAPAROTOMY PACK
ttt. URO/GEN ROBOTIC PACK
uuu. BASIC ROBOTIC PACK
vvv. LAPAROSCOPIC GYN PACK
www. PK, ROBOTICS-GYN
xxx. PQ CHG CTRY GYN LAP PK
yyy. GYN DAVINCI PACK
zzz. ROBOT GYN SHARED
aaaa. PK, ROBOTICS-GEN
bbbb. DAVINCI PACK
cccc. ROBOTIC GYN PACK
dddd. ROBOTICS PACK
eeee. PK- ROBOTICS
ffff. GYN LAPAROSCOPY
gggg. GU ROBOTIC PACK
hhhh. GYN PACK
iiii. BASIC GYN PACK
jjjj. BWH GYN ROBOTICS PACK
kkkk. BWH GU ROBOTICS PACK
llll. URO GYN PACK
mmmm. GYN LAP PACK
nnnn. GYN LAPAROSCOPY
oooo. ROBOTIC
pppp. GYN ROBOTIC
qqqq. CV ROBOTIC SET UP
rrrr. GYN LAPAROSCOPY
ssss. ROBOTIC LAVH
tttt. ROBOTIC LAP CHOLE
uuuu. GYN LAPAROSCOPY
vvvv. GYN LAPAROSCOPY
wwww. GYN ROBOTIC
xxxx. GYN ENDOSCOPY-LF
yyyy. GYN LAPAROSCOPY
zzzz. LAP ROBOTIC
aaaaa. TUBAL LIGATION CDS
bbbbb. GYN LAPAROSCOPY
ccccc. ROBOTIC GYN & GU
ddddd. ROBOTIC
eeeee. GYN LAPAROSCOPY
fffff. ROBOT GYN
ggggg. GYN LAPAROSCOPY
hhhhh. FHWC ROBOTIC
iiiii. GYN LAPAROSCOPY
jjjjj. GYN LAPAROSCOPY
kkkkk. ROBOTIC
lllll. PELVISCOPY
mmmmm. GENERAL ROBOT-TCN
nnnnn. ROBOTICS
ooooo. CVOR ROBOT
ppppp. GU-GEN ROBOTIC
qqqqq. FLOYD LAP GYN
rrrrr. GYN ROBOTIC
sssss. GYN LAPAROSCOPY CDS
ttttt. LAP TUBAL
uuuuu. DAVINCI GENERAL
vvvvv. DAVINCI LOW ANTERIOR RESECTION
wwwww. GYN
xxxxx. PELVISCOPY PACK
yyyyy. GYN LAPAROSCOPY STD PACK-LF
zzzzz. LAP GYN PACK-LF |
|---|
| Code Information |
a. GYN-URO LAPSCP CDS-LF, Item Number: CDS981583U, Case UDI/GTIN: 40195327209767, Unit UDI/GTIN: 10195327209766, Lot Number: 22JBE255;
b. ROBOTIC CDS, Item Number: CDS981882W, Case UDI/GTIN: 40195327144983, Unit UDI/GTIN: 10195327144982, Lot Number: 22IBR176;
c. GYN LAPAROSCOPY CDS-LF, Item Number: CDS981988I, Case UDI/GTIN: 40193489744164, Unit UDI/GTIN: 10193489744163, Lot Number: 22KBF564,22JBV989;
d. GYN LAPAROSCOPY, Item Number: CDS982032Y, Case UDI/GTIN: 40195327248858, Unit UDI/GTIN: 10195327248857, Lot Number: 22JBE743;
e. GYN LAPAROSCOPY CDS, Item Number: CDS982371G, Case UDI/GTIN: 40193489209397, Unit UDI/GTIN: 10193489209396, Lot Number: 22JBU375,22JBU054;
f. UNIVERSAL ROBOTIC ORLANDO, Item Number: CDS982857K, Case UDI/GTIN: 40193489927864, Unit UDI/GTIN: 10193489927863, Lot Number: 22IBA586;
g. GYN ROBOTIC CDS, Item Number: CDS982888M, Case UDI/GTIN: 40195327110698, Unit UDI/GTIN: 10195327110697, Lot Number: 22JBK498;
h. GYN LAPAROSCOPY CDS-1, Item Number: CDS982892F, Case UDI/GTIN: 40889942216926, Unit UDI/GTIN: 10889942216925, Lot Number: 22JBI848;
i. CUH GYN LAPAROSCOPY CDS, Item Number: CDS983206L, Case UDI/GTIN: 40195327164592, Unit UDI/GTIN: 10195327164591, Lot Number: 22JBM358;
j. CUH GEN/GYN ROBOTIC CDS, Item Number: CDS983375L, Case UDI/GTIN: 40195327164547, Unit UDI/GTIN: 10195327164546, Lot Number: 22JBI299;
k. LAVH CDS-LF, Item Number: CDS983868F, Case UDI/GTIN: 40889942017233, Unit UDI/GTIN: 10889942017232, Lot Number: 22JDB254;
l. GYN LAPAROSCOPY CDS-LF, Item Number: CDS984536J, Case UDI/GTIN: 40193489831345, Unit UDI/GTIN: 10193489831344, Lot Number: 22IDB843;
m. GYN LAPAROSCOPY CDS UCC-LF, Item Number: CDS984684D, Case UDI/GTIN: 40193489571364, Unit UDI/GTIN: 10193489571363, Lot Number: 22JBR850,22JBE881,22IBV318;
n. DAY SURG GYN LAP CDS, Item Number: CDS984996K, Case UDI/GTIN: 40195327175772, Unit UDI/GTIN: 10195327175771, Lot Number: 22JBD508;
o. GYN LAPAROSCOPY CDS, Item Number: CDS985217J, Case UDI/GTIN: 40195327110841, Unit UDI/GTIN: 10195327110840, Lot Number: 22KBC728,22IBA646;
p. DAVINCI HYSTERECTOMY CDS, Item Number: CDS985344D, Case UDI/GTIN: 40193489905527, Unit UDI/GTIN: 10193489905526, Lot Number: 22IBR928,22IBS195;
q. GYN LAP/ROBOTIC, Item Number: CDS985466G, Case UDI/GTIN: 40195327043118, Unit UDI/GTIN: 10195327043117, Lot Number: 22JDB080;
r. DAVINCI PACK-LF, Item Number: DYNJ0046535D, Case UDI/GTIN: 40195327095667, Unit UDI/GTIN: 10195327095666, Lot Number: 22JMH534;
s. DAVINCI PACK-LF, Item Number: DYNJ0161960F, Case UDI/GTIN: 40195327171521, Unit UDI/GTIN: 10195327171520, Lot Number: 22IDB492,22IDA146;
t. GYN LAPAROSCOPY PACK-LF, Item Number: DYNJ01910K, Case UDI/GTIN: 40193489962803, Unit UDI/GTIN: 10193489962802, Lot Number: 22IBU972;
u. ROBOTIC PACK, Item Number: DYNJ02457K, Case UDI/GTIN: 40195327108923, Unit UDI/GTIN: 10195327108922, Lot Number: 22JMG295;
v. GYN LAP - UNIV, Item Number: DYNJ0375503L, Case UDI/GTIN: 40193489943215, Unit UDI/GTIN: 10193489943214, Lot Number: 22JBP432;
w. BASIC LAVH PACK, Item Number: DYNJ0378714G, Case UDI/GTIN: 40889942435266, Unit UDI/GTIN: 10889942435265, Lot Number: 22IBI287;
x. GYN/LAPAROSCOPY PACK-LF, Item Number: DYNJ0395118K, Case UDI/GTIN: 40195327063895, Unit UDI/GTIN: 10195327063894, Lot Number: 22JBS258;
y. LAPAROSCOPIC GYN PACK-LF, Item Number: DYNJ04718T, Case UDI/GTIN: 40193489444873, Unit UDI/GTIN: 10193489444872, Lot Number: 22JMC979;
z. DAVINCI PACK-LF, Item Number: DYNJ0556546D, Case UDI/GTIN: 40195327271726, Unit UDI/GTIN: 10195327271725, Lot Number: 22JMI211;
aa. SCC GYN LAPAROSCOPY PACK, Item Number: DYNJ16604R, Case UDI/GTIN: 40195327218615, Unit UDI/GTIN: 10195327218614, Lot Number: 22JMB584;
bb. URO GYN PACK-LF, Item Number: DYNJ17454M, Case UDI/GTIN: 40193489776028, Unit UDI/GTIN: 10193489776027, Lot Number: 22IBN968,22HBK091;
cc. GYN LAPAROSCOPY PACK, Item Number: DYNJ30301D, Case UDI/GTIN: 40889942764953, Unit UDI/GTIN: 10889942764952, Lot Number: 22JBX986;
dd. TUBAL PACK, Item Number: DYNJ30481G, Case UDI/GTIN: 40193489912891, Unit UDI/GTIN: 10193489912890, Lot Number: 22JMA315;
ee. GYN LAP PACK-LF, Item Number: DYNJ32754M, Case UDI/GTIN: 40193489588980, Unit UDI/GTIN: 10193489588989, Lot Number: 22IMD300,22IMD302;
ff. LAVH PACK, Item Number: DYNJ36508B, Case UDI/GTIN: 40889942715764, Unit UDI/GTIN: 10889942715763, Lot Number: 22JBJ622;
gg. GYN LAPAROSCOPY-LF, Item Number: DYNJ36713B, Case UDI/GTIN: 40195327148035, Unit UDI/GTIN: 10195327148034, Lot Number: 22JBG940,22HBR656;
hh. LAVH PACK, Item Number: DYNJ37785B, Case UDI/GTIN: 40888277792280, Unit UDI/GTIN: 10888277792289, Lot Number: 22IBK833;
ii. PK-GYN-LAPAROSCOPY, Item Number: DYNJ42386D, Case UDI/GTIN: 40195327253340, Unit UDI/GTIN: 10195327253349, Lot Number: 22JMH924;
jj. MAJOR LAP PACK 2-LF, Item Number: DYNJ42635D, Case UDI/GTIN: 40193489919425, Unit UDI/GTIN: 10193489919424, Lot Number: 22JBW532,22JBH135,22IBD371;
kk. TUBAL PACK, Item Number: DYNJ42636, Case UDI/GTIN: 40888277003577, Unit UDI/GTIN: 10888277003576, Lot Number: 22KBA571;
ll. GYN LAPAROSCOPY PACK-LF, Item Number: DYNJ42838B, Case UDI/GTIN: 40193489880374, Unit UDI/GTIN: 10193489880373, Lot Number: 22IBT573,22HBY144;
mm. PK, ROBOTICS-GYN, Item Number: DYNJ43715B, Case UDI/GTIN: 40193489322911, Unit UDI/GTIN: 10193489322910, Lot Number: 22IBU770;
nn. SVMMC GEN ROBOTIC PACK, Item Number: DYNJ43770L, Case UDI/GTIN: 40193489989992, Unit UDI/GTIN: 10193489989991, Lot Number: 22JBT938,22IBC524;
oo. SVMMC GYN ROBOTIC PACK, Item Number: DYNJ43782K, Case UDI/GTIN: 40193489989893, Unit UDI/GTIN: 10193489989892, Lot Number: 22JBM498,22IBD372;
pp. PACK, GYN-D&C, Item Number: DYNJ43931C, Case UDI/GTIN: 40193489431606, Unit UDI/GTIN: 10193489431605, Lot Number: 22JMD510;
qq. DA VINCI PROSTATE/COLPOPEXY, Item Number: DYNJ44864S, Case UDI/GTIN: 40195327127627, Unit UDI/GTIN: 10195327127626, Lot Number: 22HBY159;
rr. ROBOT PACK, Item Number: DYNJ45184F, Case UDI/GTIN: 40195327191475, Unit UDI/GTIN: 10195327191474, Lot Number: 22JBD483;
ss. PK, GYN-LAPAROSCOPY, Item Number: DYNJ46271A, Case UDI/GTIN: 40193489338295, Unit UDI/GTIN: 10193489338294, Lot Number: 22IBS007;
tt. LAPAROSCOPIC GYN PACK, Item Number: DYNJ47274L, Case UDI/GTIN: 40195327263943, Unit UDI/GTIN: 10195327263942, Lot Number: 22JMI249,22JMA188;
uu. DAVINCI PACK-RFD, Item Number: DYNJ47762M, Case UDI/GTIN: 40195327105434, Unit UDI/GTIN: 10195327105433, Lot Number: 22JME004,22JMD998;
vv. GYN ROBOTIC PACK, Item Number: DYNJ47766Q, Case UDI/GTIN: 40195327270002, Unit UDI/GTIN: 10195327270001, Lot Number: 22JDB952;
ww. LAVH PACK, Item Number: DYNJ48599, Case UDI/GTIN: 40888277915115, Unit UDI/GTIN: 10888277915114, Lot Number: 22JBC120;
xx. ST. ANNE'S MULTI PORT PACK, Item Number: DYNJ48638G, Case UDI/GTIN: 40195327109159, Unit UDI/GTIN: 10195327109158, Lot Number: 22IBP249;
yy. LAVH PACK, Item Number: DYNJ49353, Case UDI/GTIN: 40888277846761, Unit UDI/GTIN: 10888277846760, Lot Number: 22IBN984;
zz. SOUTH SC RFT GYN LAP PACK, Item Number: DYNJ50840A, Case UDI/GTIN: 40889942221371, Unit UDI/GTIN: 10889942221370, Lot Number: 22JMI259,22JMC606;
aaa. GYN LAPAROSCOPY PACK, Item Number: DYNJ51102B, Case UDI/GTIN: 40193489985338, Unit UDI/GTIN: 10193489985337, Lot Number: 22JDB774;
bbb. LITHOTOMY PENILE PACK, Item Number: DYNJ51161C, Case UDI/GTIN: 40889942493792, Unit UDI/GTIN: 10889942493791, Lot Number: 22JBH136,22HBR181;
ccc. DAVINCI GENERAL PACK, Item Number: DYNJ51399J, Case UDI/GTIN: 40193489984492, Unit UDI/GTIN: 10193489984491, Lot Number: 22HDA632;
ddd. DAVINCI GYN PACK, Item Number: DYNJ51400J, Case UDI/GTIN: 40193489984508, Unit UDI/GTIN: 10193489984507, Lot Number: 22IDA309;
eee. DAVINCI GYN PACK, Item Number: DYNJ51400K, Case UDI/GTIN: 40195327277605, Unit UDI/GTIN: 10195327277604, Lot Number: 22JDB871;
fff. ROBOTIC PROSTATE PACK, Item Number: DYNJ52085M, Case UDI/GTIN: 40195327210374, Unit UDI/GTIN: 10195327210373, Lot Number: 22JDB086;
ggg. GYN ROBOTIC PACK-LF, Item Number: DYNJ52432J, Case UDI/GTIN: 40195327073979, Unit UDI/GTIN: 10195327073978, Lot Number: 22JDB177;
hhh. SCRIPPS SW ROBOTIC PACK, Item Number: DYNJ52564D, Case UDI/GTIN: 40195327176427, Unit UDI/GTIN: 10195327176426, Lot Number: 22HMF120,22HME681,22HME682,22FMB534;
iii. GYN LITHOTOMY PACK, Item Number: DYNJ53327A, Case UDI/GTIN: 40889942592938, Unit UDI/GTIN: 10889942592937, Lot Number: 22JMG479;
jjj. GYN LAPAROSCOPY PACK, Item Number: DYNJ53631G, Case UDI/GTIN: 40195327145430, Unit UDI/GTIN: 10195327145439, Lot Number: 22IBT104;
kkk. DEACONESS PELVIC LAP PACK, Item Number: DYNJ53820A, Case UDI/GTIN: 40195327132188, Unit UDI/GTIN: 10195327132187, Lot Number: 22IBL549;
lll. WOMENS ROBOT PACK, Item Number: DYNJ53857A, Case UDI/GTIN: 40193489497664, Unit UDI/GTIN: 10193489497663, Lot Number: 22IBD203;
mmm. GYN LAPAROSCOPY PACK-LF, Item Number: DYNJ54367, Case UDI/GTIN: 40889942478881, Unit UDI/GTIN: 10889942478880, Lot Number: 22JMG368;
nnn. MAJOR GYN PACK, Item Number: DYNJ55693I, Case UDI/GTIN: 40193489847575, Unit UDI/GTIN: 10193489847574, Lot Number: 22IBL365;
ooo. GYN LAPAROSCOPY PACK, Item Number: DYNJ56441, Case UDI/GTIN: 40889942646426, Unit UDI/GTIN: 10889942646425, Lot Number: 22HBH543;
ppp. TUBAL PACK-LF, Item Number: DYNJ56657, Case UDI/GTIN: 40889942666271, Unit UDI/GTIN: 10889942666270, Lot Number: 22IMB764;
qqq. PK, GYN-LAPAROSCOPY, Item Number: DYNJ57609B, Case UDI/GTIN: 40195327244577, Unit UDI/GTIN: 10195327244576, Lot Number: 22IMI129;
rrr. LAVH PACK, Item Number: DYNJ57740, Case UDI/GTIN: 40889942773689, Unit UDI/GTIN: 10889942773688, Lot Number: 22IBL578;
sss. LAPAROTOMY PACK, Item Number: DYNJ59079D, Case UDI/GTIN: 40195327200252, Unit UDI/GTIN: 10195327200251, Lot Number: 22JBC271,22HBF903;
ttt. URO/GEN ROBOTIC PACK, Item Number: DYNJ60803J, Case UDI/GTIN: 40195327138821, Unit UDI/GTIN: 10195327138820, Lot Number: 22KDA153,22IDA962;
uuu. BASIC ROBOTIC PACK, Item Number: DYNJ62750B, Case UDI/GTIN: 40193489975858, Unit UDI/GTIN: 10193489975857, Lot Number: 22KBC719,22HBV643,22HBI644;
vvv. LAPAROSCOPIC GYN PACK, Item Number: DYNJ62831B, Case UDI/GTIN: 40193489887274, Unit UDI/GTIN: 10193489887273, Lot Number: 22JDC183;
www. PK, ROBOTICS-GYN, Item Number: DYNJ63445B, Case UDI/GTIN: 40193489318396, Unit UDI/GTIN: 10193489318395, Lot Number: 22JBC766,22IBI894;
xxx. PQ CHG CTRY GYN LAP PK, Item Number: DYNJ64039A, Case UDI/GTIN: 40195327263585, Unit UDI/GTIN: 10195327263584, Lot Number: 22JMC821;
yyy. GYN DAVINCI PACK, Item Number: DYNJ64266, Case UDI/GTIN: 40193489795517, Unit UDI/GTIN: 10193489795516, Lot Number: 22JDB068;
zzz. ROBOT GYN SHARED, Item Number: DYNJ64793B, Case UDI/GTIN: 40195327217915, Unit UDI/GTIN: 10195327217914, Lot Number: 22JDA845,22HDC106;
aaaa. PK, ROBOTICS-GEN, Item Number: DYNJ65193A, Case UDI/GTIN: 40195327244584, Unit UDI/GTIN: 10195327244583, Lot Number: 22IMH017;
bbbb. DAVINCI PACK, Item Number: DYNJ66298D, Case UDI/GTIN: 40195327095896, Unit UDI/GTIN: 10195327095895, Lot Number: 22JBQ463;
cccc. ROBOTIC GYN PACK, Item Number: DYNJ68688A, Case UDI/GTIN: 40195327095872, Unit UDI/GTIN: 10195327095871, Lot Number: 22JBK548;
dddd. ROBOTICS PACK, Item Number: DYNJ69869, Case UDI/GTIN: 40193489992244, Unit UDI/GTIN: 10193489992243, Lot Number: 22HBY203;
eeee. PK- ROBOTICS, Item Number: DYNJ69869A, Case UDI/GTIN: 40195327252558, Unit UDI/GTIN: 10195327252557, Lot Number: 22JBL867;
ffff. GYN LAPAROSCOPY, Item Number: DYNJ69893A, Case UDI/GTIN: 40195327235018, Unit UDI/GTIN: 10195327235017, Lot Number: 22JBC621,22IBI272;
gggg. GU ROBOTIC PACK, Item Number: DYNJ82464, Case UDI/GTIN: 40195327197187, Unit UDI/GTIN: 10195327197186, Lot Number: 22HBJ903;
hhhh. GYN PACK, Item Number: DYNJ82488, Case UDI/GTIN: 40195327197446, Unit UDI/GTIN: 10195327197445, Lot Number: 22HBJ906;
iiii. BASIC GYN PACK, Item Number: DYNJ82505, Case UDI/GTIN: 40195327198306, Unit UDI/GTIN: 10195327198305, Lot Number: 22HBI366;
jjjj. BWH GYN ROBOTICS PACK, Item Number: DYNJ82559, Case UDI/GTIN: 40195327197958, Unit UDI/GTIN: 10195327197957, Lot Number: 22HBQ038;
kkkk. BWH GU ROBOTICS PACK, Item Number: DYNJ82560, Case UDI/GTIN: 40195327197965, Unit UDI/GTIN: 10195327197964, Lot Number: 22HBQ039;
llll. URO GYN PACK, Item Number: DYNJ82621, Case UDI/GTIN: 40195327199075, Unit UDI/GTIN: 10195327199074, Lot Number: 22HBT063;
mmmm. GYN LAP PACK, Item Number: DYNJ82624, Case UDI/GTIN: 40195327199105, Unit UDI/GTIN: 10195327199104, Lot Number: 22HBN265;
nnnn. GYN LAPAROSCOPY, Item Number: DYNJ900262, Case UDI/GTIN: 40888277206473, Unit UDI/GTIN: 10888277206472, Lot Number: 22JBR395,22IBT179;
oooo. ROBOTIC, Item Number: DYNJ900524K, Case UDI/GTIN: 40193489995290, Unit UDI/GTIN: 10193489995299, Lot Number: 22JDB906,22IDA179;
pppp. GYN ROBOTIC, Item Number: DYNJ901046G, Case UDI/GTIN: 40193489820967, Unit UDI/GTIN: 10193489820966, Lot Number: 22JBW050;
qqqq. CV ROBOTIC SET UP, Item Number: DYNJ901082C, Case UDI/GTIN: 40193489927659, Unit UDI/GTIN: 10193489927658, Lot Number: 22JBD190,22IBV320;
rrrr. GYN LAPAROSCOPY, Item Number: DYNJ901208C, Case UDI/GTIN: 40193489313636, Unit UDI/GTIN: 10193489313635, Lot Number: 22KBF260;
ssss. ROBOTIC LAVH, Item Number: DYNJ901281F, Case UDI/GTIN: 40193489961158, Unit UDI/GTIN: 10193489961157, Lot Number: 22IBQ970;
tttt. ROBOTIC LAP CHOLE, Item Number: DYNJ901282I, Case UDI/GTIN: 40193489961165, Unit UDI/GTIN: 10193489961164, Lot Number: 22JBI004,22IBT626;
uuuu. GYN LAPAROSCOPY, Item Number: DYNJ901370J, Case UDI/GTIN: 40195327245451, Unit UDI/GTIN: 10195327245450, Lot Number: 22JBR464;
vvvv. GYN LAPAROSCOPY, Item Number: DYNJ901774F, Case UDI/GTIN: 40193489945677, Unit UDI/GTIN: 10193489945676, Lot Number: 22JBX890,22JBA940;
wwww. GYN ROBOTIC, Item Number: DYNJ901796K, Case UDI/GTIN: 40193489979702, Unit UDI/GTIN: 10193489979701, Lot Number: 22IBD418;
xxxx. GYN ENDOSCOPY-LF, Item Number: DYNJ901812J, Case UDI/GTIN: 40193489814164, Unit UDI/GTIN: 10193489814163, Lot Number: 22JDB621,22JDA090;
yyyy. GYN LAPAROSCOPY, Item Number: DYNJ902371I, Case UDI/GTIN: 40195327223459, Unit UDI/GTIN: 10195327223458, Lot Number: 22KBH351;
zzzz. LAP ROBOTIC, Item Number: DYNJ902384J, Case UDI/GTIN: 40193489978088, Unit UDI/GTIN: 10193489978087, Lot Number: 22JBD080;
aaaaa. TUBAL LIGATION CDS, Item Number: DYNJ902721D, Case UDI/GTIN: 40193489907927, Unit UDI/GTIN: 10193489907926, Lot Number: 22JBW509;
bbbbb. GYN LAPAROSCOPY, Item Number: DYNJ903422F, Case UDI/GTIN: 40193489700320, Unit UDI/GTIN: 10193489700329, Lot Number: 22KBF386,22JBN707;
ccccc. ROBOTIC GYN & GU, Item Number: DYNJ903459F, Case UDI/GTIN: 40195327200375, Unit UDI/GTIN: 10195327200374, Lot Number: 22IBD806,22IBE664;
ddddd. ROBOTIC, Item Number: DYNJ903485G, Case UDI/GTIN: 40195327172528, Unit UDI/GTIN: 10195327172527, Lot Number: 22JDB549;
eeeee. GYN LAPAROSCOPY, Item Number: DYNJ903812C, Case UDI/GTIN: 40193489274111, Unit UDI/GTIN: 10193489274110, Lot Number: 22JBH771,22JBH772;
fffff. ROBOT GYN, Item Number: DYNJ904709F, Case UDI/GTIN: 40195327159963, Unit UDI/GTIN: 10195327159962, Lot Number: 22JBW052;
ggggg. GYN LAPAROSCOPY, Item Number: DYNJ904713A, Case UDI/GTIN: 40193489674300, Unit UDI/GTIN: 10193489674309, Lot Number: 22JBX929,22JBE278;
hhhhh. FHWC ROBOTIC, Item Number: DYNJ905195F, Case UDI/GTIN: 40195327216482, Unit UDI/GTIN: 10195327216481, Lot Number: 22IBQ982;
iiiii. GYN LAPAROSCOPY, Item Number: DYNJ905797B, Case UDI/GTIN: 40193489800815, Unit UDI/GTIN: 10193489800814, Lot Number: 22JMC890;
jjjjj. GYN LAPAROSCOPY, Item Number: DYNJ906120C, Case UDI/GTIN: 40195327223701, Unit UDI/GTIN: 10195327223700, Lot Number: 22JDB406;
kkkkk. ROBOTIC, Item Number: DYNJ906508B, Case UDI/GTIN: 40195327026524, Unit UDI/GTIN: 10195327026523, Lot Number: 22JMD368;
lllll. PELVISCOPY, Item Number: DYNJ906536A, Case UDI/GTIN: 40193489815055, Unit UDI/GTIN: 10193489815054, Lot Number: 22KBB847,22KBA201;
mmmmm. GENERAL ROBOT-TCN, Item Number: DYNJ906552D, Case UDI/GTIN: 40195327144860, Unit UDI/GTIN: 10195327144869, Lot Number: 22KBH170,22IBU705,22IBA547;
nnnnn. ROBOTICS, Item Number: DYNJ906683B, Case UDI/GTIN: 40195327225705, Unit UDI/GTIN: 10195327225704, Lot Number: 22JBR762;
ooooo. CVOR ROBOT, Item Number: DYNJ906692A, Case UDI/GTIN: 40195327061532, Unit UDI/GTIN: 10195327061531, Lot Number: 22IBT518;
ppppp. GU-GEN ROBOTIC, Item Number: DYNJ906876C, Case UDI/GTIN: 40195327110681, Unit UDI/GTIN: 10195327110680, Lot Number: 22JBD052,22JBB138;
qqqqq. FLOYD LAP GYN, Item Number: DYNJ906931C, Case UDI/GTIN: 40193489921299, Unit UDI/GTIN: 10193489921298, Lot Number: 22KBE721,22KBB791,22JBA952;
rrrrr. GYN ROBOTIC, Item Number: DYNJ907492D, Case UDI/GTIN: 40195327247462, Unit UDI/GTIN: 10195327247461, Lot Number: 22JBA125;
sssss. GYN LAPAROSCOPY CDS, Item Number: DYNJ907841A, Case UDI/GTIN: 40195327018321, Unit UDI/GTIN: 10195327018320, Lot Number: 22JBO683;
ttttt. LAP TUBAL, Item Number: DYNJ907883A, Case UDI/GTIN: 40195327019151, Unit UDI/GTIN: 10195327019150, Lot Number: 22KBH354,22JBO108;
uuuuu. DAVINCI GENERAL, Item Number: DYNJ908477A, Case UDI/GTIN: 40195327191925, Unit UDI/GTIN: 10195327191924, Lot Number: 22JMG912,22JMF336;
vvvvv. DAVINCI LOW ANTERIOR RESECTION, Item Number: DYNJ908479A, Case UDI/GTIN: 40195327192021, Unit UDI/GTIN: 10195327192020, Lot Number: 22JBQ504;
wwwww. GYN, Item Number: DYNJ908504A, Case UDI/GTIN: 40195327251292, Unit UDI/GTIN: 10195327251291, Lot Number: 22JBR467,22JBR815;
xxxxx. PELVISCOPY PACK, Item Number: DYNJT2136M, Case UDI/GTIN: 40195327109067, Unit UDI/GTIN: 10195327109066, Lot Number: 22IME712;
yyyyy. GYN LAPAROSCOPY STD PACK-LF, Item Number: PHS38678001B, Case UDI/GTIN: 40193489636612, Unit UDI/GTIN: 10193489636611, Lot Number: 22HBX127;
zzzzz. LAP GYN PACK-LF, Item Number: PHS988229I, Case UDI/GTIN: 40193489766036, Unit UDI/GTIN: 10193489766035, Lot Number: 22JMG416,22IME802 |
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Karin Johnson
886-359-1704 |
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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. |
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FDA Determined
Cause 2 | Device Design |
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| 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 | 8,064 cases (12,425 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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