Class 2 Device Recall Medline convenience kits containing

• Date Initiated by Firm: March 09, 2020
• Create Date: May 15, 2020
• Recall Status: Terminated on February 22, 2022
• Recall Number: Z-2040-2020
• Recall Event ID: 85581
• Product Classification: General surgery tray - Product Code LRO
• Product: Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows:; Part Description Part Number; ABDOMINAL HYSTERECTOMY DYNJ906478; ABDOMINAL HYSTERECTOMY DYNJ906478A; ACCESSORY HIP PACK-LF DYNJ0781865M; ARTHRO/SHOULDER PACK DYNJ30056J; ARTHRO/SHOULDER PACK DYNJ30056K; ARTHRO/SHOULDER PACK DYNJ30056L; ARTHRO/SHOULDER PACK DYNJ30056M; BODY PACK DYNJ55107A; BODY PACK DYNJ55107C; BODY PACK DYNJ55107D; C SECTION CDS CDS984613D; C SECTION CDS CDS830172I; C SECTION CDS CDS984613F; C SECTION CDS CDS830172J; C SECTION PACK CMPJ17294I; C SECTION PACK-LF DYNJ64834; CARDIAC A & B SJ PACK DYNJ0619768D; CARDIAC PROCEDURE PACK DYNJ63700; CLOSURE CDS CDS983704D; CLOSURE CDS CDS983704F; CLOSURE CDS CDS983704G; COLECTOMY LAPAROSCOPIC DYNJ906875; COLORECTAL ME DYNJ906437; CRANIOTOMY DYNJ905330A; CRANIOTOMY DYNJ905330B; C-SECTION PACK DYNJ32884F; C-SECTION PACK DYNJ32884G; C-SECTION PACK DYNJ32884I; C-SECTION PACK DYNJ32884J; C-SECTION TRAY DYNJ62707; CYSTO DYNJ901329B; CYSTO DYNJ901608B; CYSTO DYNJ903225I; CYSTO CDS982015O; CYSTO DYNJ903225J; CYSTO CDS982015P; CYSTO DYNJ903225K; CYSTO DYNJ906481; CYSTO DYNJ903225L; CYSTO CDS CDS985376C; CYSTO CDS-LF CDS982481I; CYSTO CDS-LF CDS982481J; CYSTO CDS-LF CDS982481K; CYSTO CDS-LF CDS982481L; CYSTO PACK DYNJ05177G; CYSTO PACK DYNJ51350A; CYSTO PACK DYNJ37252F; CYSTO PACK DYNJV0052L; CYSTO PACK DYNJ37680D; CYSTO PACK DYNJ58223; CYSTO PACK DYNJ53570A; CYSTO PACK CMPJ01845I; CYSTO PACK DYNJ37252G; CYSTO PACK DYNJ37252I; CYSTO PACK-LF DYNJ24911D; CYSTO PACK-LF CMPJ02168J; CYSTO PACK-LF DYNJ30470B; CYSTO PACK-LF CMPJ02168K; CYSTO PACK-LF DYNJ51350B; CYSTO PACK-LF DYNJ51350C; CYSTO TRAY-LF DYNJ42146A; CYSTO/UROLOGY PACK DYNJ64197; CYSTO-LF DYNJ50098; CYSTOSCOPY-LF DYNJ22891I; D&C HYSTEROSCOPY DYNJ901049B; D&C HYSTEROSCOPY DYNJ901049C; D&C HYSTEROSCOPY DYNJ901049D; D&C HYSTEROSCOPY PACK CMPJ43148C; D&C HYSTEROSCOPY PACK CMPJ43148D; D&C HYSTEROSCOPY PACK CMPJ43148F; D&C PACK DYNJ33603D; D&C PACK DYNJ22567C; D&C PACK DYNJ22567D; D&C PACK DYNJ55814B; D&C PACK-LF DYNJ22567F; D&C/GYN-LF DYNJ61949; D&C/GYN-LF DYNJ61949A; D&C-LF DYNJ50099A; D&C-LF DYNJ906482; DELIVERY PACK SMMC-LF DYNJ35244D; DELIVERY PACK SMMC-LF DYNJ35244F; DENTAL ENT PACK-LF DYNJ43405B; DR H PACK DYNJ62374; DR. S PACK DYNJ60499; EAR DYNJ906058A; EAR DYNJ906058B; EAR DYNJ906058F; GEN PLASTIC DYNJ901298A; GENERAL DELIVERY PACK-LF DYNJ15915F; GENERAL PACK DYNJ37894B; GENERAL PACK DYNJ61784; G S CYSTO PACK DYNJ62403; G CYSTO CDS CDS984190G; G CYSTO CDS CDS984190I; G CYSTO CDS CDS984190J; G D & C CDS CDS984203F; G D & C CDS CDS984203G; G D & C CDS CDS984203I; G D & C CDS CDS984203J; G LASER VEIN CDS CDS984193M; G LASER VEIN CDS CDS984193N; G PELVISCOPY CDS CDS984187M; G PELVISCOPY CDS CDS984187N; G PELVISCOPY CDS CDS984187O; G PELVISCOPY CDS CDS984187P; G VAGINAL CDS CDS984201M; G VAGINAL CDS CDS984201O; G VAGINAL CDS CDS984201P; G VAGINAL CDS CDS984201Q; GU SEED PACK-RF-LF DYNJ01631F; GU-GEN ROBOTIC PACK CMPJ11121; GYN LAPAROSCOPY DYNJ903869; GYN LAPAROSCOPY DYNJ901636B; GYN LAPAROSCOPY DYNJ902101A; GYN LAPAROSCOPY DYNJ37256D; GYN LAPAROSCOPY DYNJ903869A; GYN LAPAROSCOPY DYNJ903869B; GYN LAPAROSCOPY DYNJ903869C; GYN LAPAROSCOPY DYNJ903869D; GYN LAPAROSCOPY CDS CDS983410C; GYN LAPAROSCOPY CDS CDS985217D; GYN LAPAROSCOPY CDS CDS983410D; GYN LAPAROSCOPY CDS CDS985217F; GYN LAPAROSCOPY CDS CDS983410F; GYN LAPAROSCOPY CDS CDS985217G; GYN LAPAROSCOPY PACK DYNJ48614C; GYN LAPAROSCOPY PACK DYNJ22568F; GYN LAPAROSCOPY PACK DYNJ22568G; GYN LAPAROSCOPY PACK DYNJ37337G; GYN LAPAROSCOPY PACK-LF DYNJ22568I; GYN LAPAROSCOPY/LAVH CDS CDS981294C; GYN LITHOTOMY PACK DYNJ48615B; GYN ONCOLOGY ME DYNJ900201G; GYN ROBOTIC DYNJ903282D; GYN ROBOTIC DYNJ903282F; GYN ROBOTIC DYNJ903282G; GYN ROBOTIC DYNJ903282I; GYN ROBOTIC DYNJ903282J; GYN ROBOTIC DYNJ903282L; GYN-URO LAPAROSCOPY DYNJ904856; GYN-URO LAPAROSCOPY DYNJ904856A; HEAD AND NECK PACK DYNJ46509C; HEART PACK A&B CMPJ22236V; HH PAIN CLINIC PACK DYNJ59488; HMT CY
• Code Information: ABDOMINAL HYSTERECTOMY, P/N DYNJ906478, Lot Numbers: 19HDC844, 19JDC085, 19KDB380 ABDOMINAL HYSTERECTOMY, P/N DYNJ906478A, Lot Number 20BDB181 ACCESSORY HIP PACK-LF, P/N DYNJ0781865M, Lot Numbers: 18BK2574, 18DK0496, 18EKA073, 18FKA858, 18GKA188, 18IKA759, 18JKD361 ARTHRO/SHOULDER PACK, P/N DYNJ30056J, Lot Numbers: 17GB8081, 18EBS087 ARTHRO/SHOULDER PACK, P/N DYNJ30056K, Lot Numbers: 18GBJ657, 18IBN476, 19ABH842, 19DBU977, 19FBP229, 19TBE271 ARTHRO/SHOULDER PACK, P/N DYNJ30056L, Lot Numbers: 19KBL220, 19LBS330 ARTHRO/SHOULDER PACK, P/N DYNJ30056M, Lot Number 20ABZ544 BODY PACK, P/N DYNJ55107A, Lot Number 17JB4285 BODY PACK, P/N DYNJ55107C, Lot Numbers: 18DB3384, 18EBM509, 18FBF508, 18GBJ600, 18OB2061 BODY PACK, P/N DYNJ55107D, Lot Numbers: 18IBI923, 19DBW962, 19FBK979, 19IBR719, 19KBW640, 20ABF961 C SECTION CDS, P/N CDS830172I, Lot Numbers: 19DKB149, 19EKB355, 19EKD509, 19FKA732 C SECTION CDS, P/N CDS830172J, Lot Numbers: 19GKA727, 19HKB802, 19IKB890, 20AKB907 C SECTION CDS, P/N CDS984613D, Lot Numbers: 17HB2334, 17HB7440, 17KB2907, 17PB0114, 181B4216, 18AB9362, 18DB1638, 18EBF441, 18FBI270, 18GBS453, 18HBW751, 18IBV731, 19ABH359, 19BBE550 C SECTION CDS, P/N CDS984613F, Lot Numbers: 19EBY391, 19HBK987, 19HBM769, 19JBJ999, 19LBQ280, 19LBW477, 19PBC882, 20ABI330 C SECTION PACK, P/N CMPJ17294I, Lot Numbers: 19CKD719, 19DKC265 C SECTION PACK-LF, P/N DYNJ64834, Lot Number 20ABI248 CARDIAC A & B SJ PACK, P/N DYNJ0619768D, Lot Number 18HDB562 CARDIAC PROCEDURE PACK, P/N DYNJ63700. Lot Numbers: 19IBB978, 19IBQ456, 19LBK302, 20ABY137 CLOSURE CDS, P/N CDS983704D, Lot Number 17DD0913 CLOSURE CDS, P/N CDS983704F, Lot Number 17KD2583 CLOSURE CDS, P/N CDS983704G, Lot Numbers: 18AD2269, 18BD0093, 18CD0389, 18DD2372, 18DD3067, 18EDA884, 18EDB908, 18EDC244, 18GDB798, 18JDA361, 18KDB026, 19EDB744, 19HDA544, 19JDB332, 19KDC356, 20BDB106 COLECTOMY LAPAROSCOPIC, P/N DYNJ906875, Lot Number 20BBN429 COLORECTAL ME, P/N DYNJ906437, Lot Numbers: 19IBU942, 19LBE886, 19LBU084 CRANIOTOMY, P/N DYNJ905330A, Lot Numbers: 19DLA623, 19FLA426, 19GLA597, 19GLA664, 19HLA050, 19HLA112, 19HLA405, 19ILA113, 19ILA494, 19JLA501 CRANIOTOMY, P/N DYNJ905330B, Lot Number 19IBJ524 C-SECTION PACK, P/N DYNJ32884F, Lot Numbers: 181B3533, 18FBG272 C-SECTION PACK, P/N DYNJ32884G, Lot Numbers: 18HBR232, 18IBH749 C-SECTION PACK, P/N DYNJ32884I, Lot Numbers: 19EBE833, 19HBN720 C-SECTION PACK, P/N DYNJ32884J, Lot Numbers: 19KBL582, 19KBO324, 20ABO814 C-SECTION TRAY, P/N DYNJ62707, Lot Numbers: 19JBD160, 19LBM327, 19LBV877, 19UBA953, 20ABV217 CYSTO, P/N CDS982015O, Lot Numbers: 19ABS422, 19EBJ364 CYSTO, P/N CDS982015P, Lot Numbers: 19GBI355, 19KBZ671, 20BBC179 CYSTO, P/N DYNJ901329B, Lot Numbers: 17DB5782, 17SB1873, 17TB3763, 181B3126, 18CB8268, 18DB7266, 18EBP366, 18GBJ122, 18IBN941, 19EBF820, 19HBL318, 19IBR381 CYSTO, P/N DYNJ901608B, Lot Numbers: 17DD1341, 17HB4160, 18AB7938, 18DB3886, 18GBM396, 18OB3272, 18PB0231 CYSTO, P/N DYNJ903225I, Lot Numbers: 18GDA854, 18HDA907, 18JDD603, 19BDB245 CYSTO, P/N DYNJ903225J, Lot Numbers: 19DDA516, 19EDC255 CYSTO, P/N YNJ903225K, Lot Number 19GDC685 CYSTO, P/N DYNJ903225L, Lot Numbers: 19IDB715, 19LDA241, 20ADA955 CYSTO, P/N DYNJ906481, Lot Numbers: 19HDC054, 19IDA135, 19JDA270 CYSTO CDS, P/N CDS985376C, Lot Numbers: 17CD3362, 17FD1685, 17SB5166, 181B3136, 18DB6407, 18FBC355 CYSTO CDS-LF, P/N CDS982481I, Lot numbers: 17CD2560, 17FD2712, 17ID3033 CYSTO CDS-LF, P/N CDS982481J, Lot Numbers: 17ID2959, 17KD2364, 18AD0022 CYSTO CDS-LF, P/N CDS982481K, Lot Numbers: 18CD2142, 18DD3133, 18EDC069, 18FDD072, 18HDB908 CYSTO CDS-LF, P/N CDS982481L, Lot Numbers: 18JDA864, 18JDD570, 18KDC289, 19BDC500, 19DDA669, 19EDC246, 19FDC061, 19HDC914, 19JDC353 CYSTO PACK, P/N CMPJ01845I, Lot Numbers: 19ABI470, 19DBW687, 19EBW036, 19IBQ992, 19KBO365, 19RBA395, 20ABQ482 CYSTO PACK, P/N DYNJ05177G, Lot Numbers: 18CB7813, 18DB0221, 18EBG111, 18GBN269.18HBM826, 18IBL346, 18OB4599, 19ABG961, 19EBL504, 19FBT436, 19HBL201, 19HBY407, 19IBW906, 19KBT077 CYSTO PACK, P/N DYNJ37252F, Lot Numbers: 18EBT920, 18GBJ640, 18HBN319, 18IBM557 CYSTO PACK, P/N DYNJ37252G, Lot Numbers: 19ABI547, 19FBS505 CYSTO PACK, P/N DYNJ37252I, Lot Numbers: 19KBS583, 19TBE301, 19UBC092, 19WBB464 CYSTO PACK, P/N DYNJ37680D, Lot Number 18GBV538 CYSTO PACK, P/N DYNJ51350A, Lot Numbers: 18DB4877, 18EBK919, 18FBO325, 18HBJ666, 18KBC537, 19ABT740, 19CBH341, 19EBS882 CYSTO PACK, P/N DYNJ53570A, Lot Number 18HDB222 CYSTO PACK, P/N DYNJ58223, Lot Numbers: 18HBL694, 19FBQ960, 19HBL410, 19IBC902, 19JBJ236, 20ABR023 CYSTO PACK, P/N DYNJV0052L, Lot Number 18GBD340 CYSTO PACK-LF, P/N CMPJ02168J, Lot Numbers: 17JB3061, 17JB3735, 18FBM695, 18PB6403, 19ABI468, 19BBH594, 19CBJ324 CYSTO PACK-LF, P/N CMPJ02168K, Lot Numbers: 19GBZ859, 19HBC382, 19KBI414, 19TBF122 CYSTO PACK-LF, P/N DYNJ24911D, Lot Number 17GB7209 CYSTO PACK-LF, P/N DYNJ30470B, lot Numbers: 19CDC616, 19FDC407, 19IDB955, 19JDA778, 20BMC152 CYSTO PACK-LF, P/N DYNJ51350B, Lot Numbers: 19HBN735, 19LBF477 CYSTO PACK-LF, P/N DYNJ51350C, Lot Number 20ABW892 CYSTO TRAY-LF, P/N DYNJ42146A, Lot Numbers: 19HBD837, 19HBE407, 19IBD980 CYSTO/UROLOGY PACK, P/N DYNJ64197, Lot Number 19JBC096 CYSTO-LF, P/N DYNJ50098, Lot Numbers: 17DB8330, 18EBF640, 18GBC446, 18HBU520, 18IBP718, 19EBY589, 19GBY696, 19HBL234, 19IBS945, 20ABO874 CYSTOSCOPY-LF, P/N DYNJ22891I, Lot Number 17TB7960 D&C HYSTEROSCOPY, P/N DYNJ901049B, Lot Numbers: 17HB3262, 17VB2282, 18DB2178, 18EBI609, 18FBU405, 18HBP426, 18IBK955 D&C HYSTEROSCOPY, P/N DYNJ901049C, Lot numbers: 19ABX760, 19CBM337, 19FBK059, 19FBM116, 19HBF529, 19IBL350 D&C HYSTEROSCOPY, P/N DYNJ901049D, Lot Numbers: 19JBX100, 19LBA456, 20ABP703 D&C HYSTEROSCOPY PACK, P/N CMPJ43148C, Lot Numbers: 17JB3557, 17SB4546, 18CB8701, 18EBA535, 18FBK071, 18HBB777, 18IBD185 D&C HYSTEROSCOPY PACK, P/N CMPJ43148D, Lot Numbers: 19ABN229, 19BBQ864, 19HBL177, 19QBA327, 19SBA378 D&C HYSTEROSCOPY PACK, P/N CMPJ43148F, Lot Numbers: 19IBS914, 19KBS184, 19LBF805 D&C PACK, P/N DYNJ22567C, Lot Numbers: 18FBE582, 18GBQ622, 18IBP274 D&C PACK, P/N DYNJ22567D, Lot Numbers: 19ABI501, 19DBW478 D&C PACK, P/N DYNJ33603D, Lot Numbers: 17GB6006, 17HB9797, 17PB1711, 18CB8541, 18EKC283, 18FKA868, 18GKB043, 18IKC857, 18KKB698, 18OB2232, 19DKA576, 19FKA118, 19GKA811, 19HKB609, 19HKD422, 19LKA215, 19LKB409 D&C PACK, P/N DYNJ55814B. Lot Numbers: 19GDB451, 19IDC776, 20AMD045 D&C PACK-LF, P/N DYNJ22567F, Lot Numbers: 19HBL690, 19KBL218, 19SBA953 D&C/GYN-LF, P/N DYNJ61949, Lot Number 19EBM592 D&C/GYN-LF, P/N DYNJ61949A, Lot Numbers: 19GBY888, 19IBL297, 19LBV170 D&C-LF, P/N DYNJ50099A. Lot Numbers: 17HB2628, 18DB7961, 18EBM869, 18FBU604, 18HBJ197, 18HBV979, 19ABG751, 19EBI012, 19FBX330, 19KBL222, 19TBB121 D&C-LF, P/N DYNJ906482, Lot Numbers: 19HDA713, 19IDA804 DELIVERY PACK SMMC-LF, P/N DYNJ35244D, Lot Numbers: 18FBM393, 18GBH816, 18HKD337, 18PB7584, 19AKB294, 19BKB498, 19CKD571, 19EKC403, 19GKA556, 19HMA095 DELIVERY PACK SMMC-LF, P/N DYNJ35244F, Lot Numbers: 19IMA154, 19KMA873, 19LMB996 DENTAL ENT PACK-LF, P/N DYNJ43405B, Lot Numbers: 17DB4711, 17JB3772, 17TB2553, 18FBG759, 18GBB950, 18HBJ782, 18IBD977, 18JBB044, 18OB1076, 19ABH001, 19BBC827, 19DBS957, 19FBF907, 19HBL266, 19IBM279, 19KBT022 DR H PACK, P/N DYNJ62374, Lot Number 19EBP988 DR. S PACK, P/N DYNJ60499, Lot Number 19RBD374 EAR, P/N DYNJ906058A, Lot Number 19GDA108 EAR, P/N DYNJ906058B, Lot Numbers: 19HDA206, 19JDA732, 19JDC699 EAR, P/N DYNJ906058F, Lot Number 20BDA056 GEN PLASTIC, P/N DYNJ901298A, Lot Numbers: 181B2961, 18CB8116, 18EBF466, 18GBN118, 18HBI800, 18LBQ349, 19ABJ846, 19ABJ847, 19GBZ327, 19HBU949, 19KBA017, 19KBA980, 19VBG309, 20ABF554 GENERAL DELIVERY PACK-LF, P/N DYNJ15915F, Lot Number 18HBH711 GENERAL PACK, P/N DYNJ37894B, Lot Number 17HB3167 GENERAL PACK, P/N DYNJ61784, Lot Numbers: 19BBD470, 19EBL664, 19HBX905 G S CYSTO PACK, P/N DYNJ62403, Lot Numbers: 19DBX932, 19HBN542, 19IBS784, 19KBL192, 20ABG016 G CYSTO CDS, P/N CDS984190G, Lot Number 181B2325 G CYSTO CDS, P/N CDS984190I, Lot Numbers: 181B3131, 18CB7673, 18FBD281, 18FBO899, 18HBB362 G CYSTO CDS, P/N CDS984190J, Lot Numbers: 19ABH369, 19DBS427, 19GBY549, 19IBL437, 19JBH122, 19LBO130, 19LBS984, 19RBA717, 20ABL126 G D & C CDS, P/N CDS984203F, Lot Numbers: 17GB4784, 17HB8483 G D & C CDS, P/N CDS984203G, Lot Numbers: 181B3401, 18CB1320, 18CB7674 G D & C CDS, P/N CDS984203I, Lot Numbers: 18FBM342, 18IBF659 G D & C CDS, P/N CDS984203J, Lot Numbers: 19BBD353, 19FBY439, 19IBI565, 19JBD283, 19KBP674 G LASER VEIN CDS, P/N CDS984193M, Lot Numbers: 18DB2757, 18GBF698, 18JBA363, 19ABQ085, 19HBT112, 19KBP612 G PELVISCOPY CDS, P/N CDS984187M, Lot Numbers: 18FBE115, 18FBM675 G PELVISCOPY CDS, P/N CDS984187N, Lot Number 18FBM344 G PELVISCOPY CDS, P/N CDS984187O, Lot Numbers: 19ABH353, 19BBD103, 19DBY244, 19FBN914, 19FBZ824, 19IBS370 G PELVISCOPY CDS, P/N CDS984187P, Lot Numbers: 19KBO494, 19LBV481 G VAGINAL CDS, P/N CDS984201M, Lot Numbers: 17XB8632, 18MB2491 G VAGINAL CDS, P/N CDS984201O, Lot Numbers: 18FBM319, 18HBU674 G VAGINAL CDS, P/N CDS984201P, Lot Numbers: 18LBB108, 19ABM987, 19HBL316, 19HBN663 G VAGINAL CDS, P/N CDS984201Q, Lot Numbers: 19KBO466, 19LBK667 GU SEED PACK-RF-LF, P/N DYNJ01631F, Lot Numbers: 17DB9147, 181B3375, 18FBP711, 18GBS615, 18HBX289, 18IBR907, 18OB7331, 19BBR302, 19EBX839, 19FBV826, 19IBF084, 19KBL213, 19VBI167, 20ABJ479 GU-GEN ROBOTIC PACK, P/N CMPJ11121, Lot Number 20ABR240 GYN LAPAROSCOPY, P/N DYNJ37256D, Lot Numbers: 18FBA393, 18GBA905, 18HBI994, 18IBB530, 19BBH066, 19FBB738, 19GBY736, 19IBH625, 19KBL223, 19VBI179 GYN LAPAROSCOPY, P/N DYNJ901636B, Lot Numbers: 17SB2071, 18BB5757, 18FBQ512, 18HBM853, 18PB7923 GYN LAPAROSCOPY, P/N DYNJ902101A, Lot Numbers: 181B2785, 18CB8273, 18EBF863, 18FBU257, 18FBU411, 18HBI816, 18IBB249, 18JBA287, 18PB6750, 19ABH397, 19DBS424, 19EBI956, 19GBY751, 19LBJ485 GYN LAPAROSCOPY, P/N DYNJ903869, Lot Numbers: 18AK1078, 18DK1205, 18GKA767 GYN LAPAROSCOPY, P/N DYNJ903869A, Lot Numbers: 18GKA741, 18JKA804 GYN LAPAROSCOPY, P/N DYNJ903869B, Lot Numbers: 18KKC773, 19AKD364 GYN LAPAROSCOPY, P/N DYNJ903869C, Lot Numbers: 19BKD564, 19DKB974, 19FKA231, 19IKA601 GYN LAPAROSCOPY, P/N DYNJ903869D, Lot Numbers: 20AKA006, 20AKB991 GYN LAPAROSCOPY CDS, P/N CDS983410C, Lot Number 17DD1216 GYN LAPAROSCOPY CDS, P/N CDS983410D, Lot Numbers: 17ID3040, 17LD2570, 18CD3284, 18EDB603, 18HDA809, 18IDC927, 18JDD116 GYN LAPAROSCOPY CDS, P/N CDS983410F, Lot Numbers: 19DDA811, 19EDD147, 19FDD052, 19HDA198, 19IDC291, 19KDC444, 20ADC688 GYN LAPAROSCOPY CDS, P/N CDS985217D, Lot Numbers: 17HB7441, 18GBP788, 18IBM691, 18OB9091 GYN LAPAROSCOPY CDS, P/N CDS985217F, Lot Numbers: 19ABJ863, 19EBF842, 19HBT513 GYN LAPAROSCOPY CDS, P/N CDS985217G, Lot Numbers: 19IBG911, 20ABN409 GYN LAPAROSCOPY PACK, P/N DYNJ22568F, Lot Numbers: 18EBG390, 18HBI973, 18IBU732 GYN LAPAROSCOPY PACK, P/N DYNJ22568G, Lot Numbers: 19ABI419, 19FBL852 GYN LAPAROSCOPY PACK, P/N DYNJ37337G, Lot Numbers: 19HDC252, 19JDA900 GYN LAPAROSCOPY PACK, P/N DYNJ48614C, Lot Numbers: 18BD1731, 18CD2115 GYN LAPAROSCOPY PACK-LF, P/N DYNJ22568I, Lot Numbers: 19GBY678, 19HBL336, 19IBK543, 19KBE481, 19KBY487, 19VBI162 GYN LAPAROSCOPY/LAVH CDS, P/N CDS981294C, Lot Numbers: 18EBM068, 18FBG907, 18FBM670 GYN LITHOTOMY PACK, P/N DYNJ48615B, Lot Numbers: 18BD3278, 18CD0320 GYN ONCOLOGY ME, P/N DYNJ900201G, Lot Numbers: 18EBP360, 18FBT379, 18GBC624, 18HBK260, 18IBJ086, 18KBC581, 19ABH365, 19BBR801, 19EBE040, 19FBM701, 19IBU923, 19KBA025, 19KBT629, 19TBB338 GYN ROBOTIC, P/N DYNJ903282D, Lot Number 17DD1218 GYN ROBOTIC, P/N DYNJ903282F, Lot Number 17ID3659 GYN ROBOTIC, P/N DYNJ903282G, Lot Numbers: 18BD3267, 18DD2946, 18FDB108 GYN ROBOTIC, P/N DYNJ903282I, Lot Number 18JDB462 GYN ROBOTIC, P/N DYNJ903282J, Lot Numbers: 19DDA820, 19EDC256 GYN ROBOTIC, P/N DYNJ903282L, Lot Numbers: 19IDB885, 20ADC687 GYN-URO LAPAROSCOPY, P/N DYNJ904856, Lot Numbers: 18GBN123, 19ABH377 GYN-URO LAPAROSCOPY, P/N DYNJ904856A, Lot Numbers: 19CBX063, 19EBO026, 19IBC630, 19KBA019 HEAD AND NECK PACK, P/N DYNJ46509C, Lot Numbers: 17DD2749, 17FD1964, 18AD3895, 18CD2143, 18DD3398, 18FDB598, 18GDC810, 18IDB557, 18JDD082, 19CDB192, 19EDC452, 19HDA393, 19JDB546, 19JMC172, 19KMA477, 19LMC795, 20BMA080 HEART PACK A&B, P/N CMPJ22236V, Lot Number 18HDC365 HH P C PACK, P/N DYNJ59488, Lot Number 18GBT192 HMT CYSTO/TUR CDS, P/N CDS984210I, Lot Numbers: 18EBO780, 18FBS573, 18HBI201, 18IBE124, 19ABQ384, 19BBN381, 19EBW019, 19FBT122, 19HBU942, 19KBY995, 20BBO913 HMT CYSTO/TUR PACK, P/N CMPJ03511F, Lot Numbers: 18EBF680, 18FBD950, 18GBP196, 18HBR630, 19ABH009, 19BBC781, 19EBH245, 19FBH291, 19HBL167, 19KBL142, 19LBR196, 19VBI145 HYSTEROSCOPY, P/N DYNJ906486, Lot Numbers: 19HDA191, 19JDB525, 20BDB115 HYSTEROSCOPY CDS LF, P/N CDS760014L, Lot Numbers: 17HB4149, 18GBA641, 18OB1647, 18PB4220, 19DBS428, 19SBB158 HYSTEROSCOPY PACK-LF, P/N DYNJ64663, Lot Numbers: 19LBD487, 20ABV679 INFANT CDS, P/N CDS982010G, Lot Numbers: 17QB2275, 17TB0096, 18FKD026, 18LKA941, 19EKA849, 19KKA538 INFANT PACK, P/N CMPJ01841G, Lot Numbers: 17DB5947, 17SB5284, 18FKA924, 18KKD136, 19DKC647, 19JKB346, 19JKB829 KNEE ARTHROSCOPY PACK, P/N DYNJ62292, Lot Number 19EDB695 LABOR DELIVERY PACK, P/N DYNJ38937A, Lot Numbers: 17ID2001, 18BD1935, 18BD2593, 18CD0105 LAMINECTOMY PACK CCMC, P/N DYNJ63806, Lot Number 19TBB711 LAP COLON CDS, P/N CDS984849G, Lot Number 18CD1684 LAP COLON CDS, P/N CDS984849I, Lot Numbers: 18EDB086, 18FDB603 LAP COLON CDS, P/N CDS984849J, Lot Numbers: 18IDA875, 18JDD526, 19BDD022, 19DDC335, 19FDC787, 19GDD038, 19IDC932, 19KDB082 LAP COLON CDS, P/N CDS984849K, Lot number 20BDB104 LAPAROSCOPY GEN SURG PACK-LF, P/N DYNJ43336C, Lot Number 19BKC483 LAPAROSCOPY PK, P/N DYNJ14073B, lot Numbers: 17GB5876, 18EBJ011, 18GBB342, 18HBV529, 18IBO477, 19ABM623, 19ABN139, 19BBC913, 19DBS604, 19FBL747, 19HBX919, 19KBL179, 19LBO706, 19SBB395, 20ABG075 LAPAROSCOPY PK/A, P/N DYNJ14072B, Lot Numbers: 17DB2518, 18FBL150, 18HBW915, 19EBE723, 19HBL644, 19LBQ947 LAVH CDS, P/N CDS983411C, Lot Number 17ID2339 LAVH CDS, P/N CDS983411D, Lot Numbers: 17KD2373, 18CD0764, 18DD1949, 18GDB364, 18HDC590, 19CDA742, 19GDA379, 19GDC090, 19IDC168, 19KDC368 LAVH PACK LF, P/N DYNJ61948, Lot Numbers: 19DBZ105, 19EBU136, 19FBU585, 19IBX918, 19LBK886 LITHOTOMY CDS, P/N CDS983407C, Lot Numbers: 17DD1199, 17DD3045 LITHOTOMY CDS, P/N CDS983407D, Lot Numbers: 17ID2958, 17LD2731, 18FDB147, 18HDC338, 18JDC741, 19DDB441, 19FDB505, 19JDC689, 20BDB165 LITHOTOMY PACK, P/N DYNJ39047, Lot Numbers: 17TB2536, 18AB8628, 18EBJ091, 18FBJ509, 18GBI763, 18IBB792, 18KBC541, 18OB9592, 19ABI727, 19DBX518, 19FBF793 LITHOTOMY PACK, P/N DYNJ39047A, Lot Numbers: 19GBY711, 19HBA662, 19JBB798, 19KBN994 MAJOR ABD/TAH-LF, P/N CDS984537F, Lot Numbers: 18GDA022, 18IDC380, 18JDA815, 19CDC227, 19EDB108, 19HDC918, 19KDA121, 19KDC344, 20ADC680 MAJOR LITHOTOMY CDS, P/N CDS983417C, Lot Numbers: 17FD2325, 17FD3078, 18CD3526, 18FDA352, 19BDD449 MAJOR SURGERY-LF, P/N DYNJ903020C, Lot Numbers: 18HBR739, 18HBS049, 19DBW990, 19EBL914, 19EBM817, 19FBA802, 20ABQ578 M CYSTO PACK, P/N DYNJ58093, Lot Numbers: 18HBB233, 18HBW642, 18PB0462, 19ABH123, 9DBV817, 19FBK826, 19HBX857, 19IBQ953, 20ABT734 MINOR PLASTICS, P/N DYNJ906674, Lot Numbers: 19KBK200, 20ABR646, 20BBA611 MINOR PLASTICS PACK, P/N CMPJ10914, Lot Numbers: 19VBI133, 20ABF797 20ABQ749 MINOR SURGERY TRAY-LF, P/N GSP457R, Lot Numbers: 17DB6161, 17TB0618, 18DB2085, 18EBO736, 18GBH834, 18HBK566, 18IBE894, 18IBT898, 19ABG729, 19EBN489, 19FBU245, 19HBX680, 19IBR504, 19LBL353, 19PBB690 NE PHLEBECTOMY, P/N DYNJ905043, Lot Numbers: 19GDC875, 19IDC605 N L CYSTO, P/N DYNJ901819A, Lot Number 17DB4356 N L CYSTO, P/N DYNJ901819B, Lot Numbers: 17TB1338, 17UB7029, 17YM0501 N L CYSTO, P/N DYNJ901819C, Lot Numbers: 18CB8118, 18DB4923, 18EBH036, 18FBN158, 18GBO154 N L CYSTO, P/N DYNJ901819D, Lot Numbers: 19BBQ417, 19EBN670, 19FBF543 N L CYSTO, P/N DYNJ901819F, Lot Numbers: 19IBJ784, 19UBA891, 20ABW759 OB DELIVERY, P/N DYNJ47087B, Lot Number 18HDC746 OB PACK, P/N DYNJ53011, Lot Numbers: 18DD1846, 18GDA690, 18IDA252 OBSTETRICAL PACK, P/N DYNJT1518G, Lot Numbers: 18BK2097, 18BK3121, 18EKB851, 18GKA941, 18HKB543, 18JKD142, 19AKA991, 19BKC597, 19DKA805, 19EKD640, 19GKB160, 19HMA314, 19IMB360, 19KMA886 OPEN HEART CDS PART A, P/N CDS840402X, Lot Number 18IDA367 OPEN HEART PACK, P/N DYNJ37284G, Lot Numbers: 19EBF334, 19EBZ932, 19GBZ628, 19HBR551, 19JBD345, 19LBQ357, 19RBB638, 19TBD811, 20ABG365, 20ABH661 OPEN UROLOGY, P/N DYNJ900931B, Lot Numbers: 18CB8114, 18EBF467 PEDS CYSTO PACK, P/N DYNJ50667C, Lot Numbers: 18FBD774, 18FBO620, 18HBC145, 18IBI918, 19ABG757, 19IBD297, 19TBA886, 20BBR224 PEDS EMERGENT PACK, P/N DYNJ52082C, Lot Numbers: 17JB3792, 18FBI159, 18IBI654, 19CBD399 PERI GYN PACK, P/N DYNJ24338F, Lot Numbers: 18CB9110, 18EBG060, 18GBO476, 18IBQ981 PERI GYN PACK, P/N DYNJ24338G, Lot Numbers: 19DBS612, 19EBK898, 19FBI590, 19HBM106, 19JBI652, 19KBL190, 19LBN038 PERI-RECTAL CDS, P/N CDS760093D, Lot Numbers: 17HB7418, 181B3103, 18FBV215, 18OB4341 PERI-RECTAL PACK, P/N DYNJ59804. Lot Numbers: 18JBT216, 19BBC701, 19EBS607, 19GBY721, 19HBV479, 19IBV115, 19KBL203, 19LBF649, 19PBB082 PODIATRY PACK, P/N DYNJ60944, Lot Numbers: 19ABI402, 19ABN578 PODIATRY PACK, P/N DYNJ60944A, Lot Numbers: 19DBW588, 19FBR457, 19LBD299, 19UBC439, 19VBI165 RECTAL, P/N DYNJ903220C, Lot Number 17ID1988 RECTAL, P/N DYNJ903220D, Lot Number 18AD3606 RECTAL, P/N DYNJ903220F, Lot Numbers: 18CD1686, 18DD1681, 18EDB689 RECTAL, P/N DYNJ903220G, Lot Numbers: 18FDC228, 18IDB587, 18KDB826 RECTAL, P/N DYNJ903220I, Lot Numbers: 19CDA628, 19FDC819, 19IDC078, 19JDC596 RECTAL, P/N DYNJ903220J, Lot Numbers: 19KDB707, 20BDB100 RECTAL CDS-LF, P/N CDS984852C, Lot Numbers: 17CD2330, 17DD0190, 17FD2907, 17JD0372, 17KD2388, 18AD0440 RECTAL CDS-LF, P/N CDS984852D, Lot Numbers: 18CD0995, 18DD2941, 18FDA019, 18GDC003, 18IDB594, 18KDC286, 19EDB748, 19GDB932, 19IDA518, 19KDB706 ROBOT ME, P/N DYNJ900203F, Lot Numbers: 18EBH941, 18GBC610, 18GBJ052, 18HBK445, 18IBK036, 19DBS419, 19EBR720, 19FBB400, 19FBU014, 19HBS886, 19IBA424, 19IBU926, 19KBA020, 19KBP685, 20ABS637 ROBOTIC, P/N DYNJ901635A, Lot Numbers: 17DD3275, 17FD3990, 17HB1255, 17JB3531, 18DB8060, 18FBC295, 18GBC687, 18OB1244, 18PB3243 ROBOTIC CDS, P/N CDS982888D, Lot Numbers: 17DB8165, 17SB5153, 17YM6115, 18AB6207, 18DB5036, 18EBF458, 18FBA049, 18GBP817, 18HBT527, 18KBC539, 18OB6970, 19ABH707 ROBOTIC CDS, P/N CDS982888F, Lot Numbers: 19BBC785, 19PBB698, 19PBC886, 19QBB894 ROBOTIC CDS, P/N CDS982888G , Lot Numbers: 19HBP405, 19HBT021, 19IBV342, 19KBA176, 19KBZ824, 19TBB421 ROBOTIC CDS, P/N CDS985029C, Lot Numbers: 17EK2596, 17JK2485, 18AK2656, 18BK0131, 18BK2708, 18DK0794, 18EKA997, 18FKD815, 18HKA238, 18IKB624, 18JKC994, 18KKC098, 19AKD191, 19BKD157, 19BKD894, 19DKA597, 19EKC600, 19FKC549, 19HKA935 ROBOTIC PACK, P/N DYNJ58969, Lot Numbers: 19GDB941, 19HDC062, 19JDC114 SHOULDER, P/N DYNJS2026B, Lot Number 17ED0553 SHOULDER, P/N DYNJS2026C, Lot Numbers: 17ID3913, 18AD3013, 18EDA813, 18EDB157, 18FDC077, 18GDB044 SHOULDER, P/N DYNJS2026D, Lot number 18KDB452 SHOULDER PACK, P/N CMPJ31997I, Lot Number 17DD2384 SHOULDER PACK, P/N CMPJ31997J, Lot Numbers: 17ID2147, 18AD0234, 18DD2234, 18DD3731, 18FDA841, 18GDA034 SHOULDER PACK, P/N CMPJ31997K, Lot number 18KDA041 S M STL ROBOTIC, P/N DYNJ905028, Lot Numbers: 181B6635, 18JBN365, 19ABT301, 19CBH042, 19EBE528, 19TBB326, 19TBB327 S M STL ROBOTIC PACK, P/N CMPJ09141, Lot Numbers: 18AB5029, 18IBV775, 19ABI405, 19BBG338, 19DBU451, 19HBN961, 19IBA037, 19UBA252 TAA GYN LAPAROSCOPY, P/N DYNJ904423A, Lot Number 19ABQ084 TOTAL HIP BOTTROS ADD-ON, P/N DYNJ906077, Lot Numbers: 19EDA155, 19HDA166, 19HDC131 TOTAL HIP BOTTROS ADD-ON, P/N DYNJ906077A, Lot Numbers: 19HDC863, 20BDC169 TOTAL HIP BOTTROS-ADD ON PK, P/N CMPJ10311, Lot Numbers: 19DDA394, 19GDB608, 19GDB695, 19GDC353 TOTAL HIP BOTTROS-ADD ON PK, P/N CMPJ10311A, Lot Numbers: 19GDD053, 19HDA172, 19IDC137 TOTAL JOINT PACK-LF, P/N DYNJ21173P, Lot Numbers: 18KBA552, 19GBB907, 19PBA125 TUR, P/N CDS982022O, Lot Numbers: 19ABZ752, 19EBF821, 19FBH986 TUR, P/N CDS982022P, Lot Numbers: 19GBL022, 19IBD013, 20ABQ521 TUR PACK, P/N CMPJ01852I, Lot Numbers: 19ABM736, 19DBT200, 19EBW748, 19HBL573, 19RBC115, 20ABG829 UROLOGY CDS-LF, P/N CDS982421J, Lot Numbers: 17WB0372, 18BB8045, 18EBK951, 18GBA601, 19ABU309, 19BBR792, 19DBG145 UROLOGY CDS-LF, P/N CDS982421K, Lot Numbers: 19HBF530, 19IBR353, 19LBA489 UROLOGY MINOR PACK, P/N DYNJ52083, Lot Number 18HDA783 UROLOGY PACC PACK, P/N DYNJ62979, Lot Numbers: 19EBY130, 19TBF385 UROLOGY PACC PACK, P/N DYNJ62979A, Lot Number 19KBS860 UROLOGY/GYN PACK-LF, P/N DYNJ61923, Lot Number 19PBB025 VAG PACK A-LF, P/N DYNJ14231C, Lot Numbers: 17GB1876, 18AB5033, 19FBI628, 19IBF349 VAGINAL DELIVERY PACK, P/N DYNJ33601F, Lot Numbers: 18HKB773, 18IKA853 VAGINAL DELIVERY PACK-LF, P/N DYNJ06300N, Lot Numbers: 18GBS674, 18IBC277 VAGINAL DELIVERY PACK-LF, P/N OBN469K, Lot Numbers: 18FBI365, 18GBR584, 18HBV018, 19ABH002, 19ABK785, 19BBD002, 19EBF115, 19HBP347, 19HBP761, 19KBL187, 19UBC182 VAGINAL HYSTERECTOMY, P/N DYNJ906493, Lot Number 19JDB209 VAGINAL HYSTERECTOMY, P/N DYNJ906493A, Lot Number 20ADC672 VAGINAL PACK, P/N DYNJ01830G, Lot Numbers: 17PB2261, 17SB8096, 18DK3434, 18FKD459, 18HKC406, 18KKA817, 19CKA309, 19EKA685, 19GKA348, 19IKA073, 19LKA216 VASCULAR, P/N DYNJ902099A, Lot numbers: 177B2283, 17PB3010, 17TB6267, 18BB4040, 18GBQ151, 18OB9215, 18PB8735, 19CBF049, 19EBU845, 19HBS485, 19LBV479 VPH LITHOTOMY MINOR-LF, P/N DYNJ902663A, Lot Number 17DK2478 VPH LITHOTOMY MINOR-LF, P/N DYNJ902663B, Lot Numbers: 17TB6309, 18EBB988, 18EBH531, 18FBM265, 18GBN599, 18HBO657, 18OB3395 VPH LITHOTOMY MINOR-LF, P/N DYNJ902663C, Lot Numbers: 19ABG913, 19KBP673, 19PBB843, 19TBF195 WMC ABD HYST PACK-LF, P/N DYNJ50650D, Lot Numbers: 18EBM879, 18FBR163, 18HBA248, 18IBD798, 18IBR303 WMC ABD HYST PACK-LF, P/N DYNJ50650F, Lot Numbers: 19ABN616, 19CBA345, 19DBT22, 19DBU824, 19EBO007, 19FBY970, 19IBL387, 19JBT416, 19KBP095, 19VBI177 WMC GYN LAPAROSCOPY PACK-LF, P/N DYNJ50649D, Lot Number 18FBM897 WMC GYN LAPAROSCOPY PACK-LF, P/N DYNJ50649F, Lot Numbers: 19ABI174, 19ABQ238 WMC GYN LAPAROSCOPY PACK-LF, P/N DYNJ50649G, Lot Numbers: 19EBV195, 19FBE652, 19FBX349, 19HBC713, 19IBW545, 19LBB519, 19LBD118, 19LBE467, 19LBO445
• Recalling Firm/ Manufacturer: Medline Industries Inc; Three Lakes Drive; Northfield IL 60093
• For Additional Information Contact: Benjamin Gora; 866-359-1704
• Manufacturer Reason for Recall: Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch.
• FDA Determined Cause: Process control
• Action: The firm initiated the recall by letter on 03/09/2020. The letter explained the problem and requested the consignee take the following actions: "1. Immediately check your stock for the specific kit number and the affected kit lot number in the attached list. Quarantine any kits with the listed lot numbers. If you dont have any of the lots listed above skip to step 3. 2. Affix the enclosed stickers on the affected kits and return to stock. If additional stickers are needed please call 866-359-1704. Please be sure NOT to use the Sterile Pre-Saturated Povidone Iodine Sponge Products components, pull another approved product from sterile supply. 3. Please fill out and return the enclosed Verification Form via email to recalls@medline.com or fax 866-767-1290. "
• Quantity in Commerce: 92,902 kits
• Distribution: nationwide
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.