—#197858

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

FDA product code: OHD — Gynecological Laparoscopic Kit
Device class: Class 2
Medical specialty: Obstetrics/Gynecology
Affected lot / code info: 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

Why it was recalled

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

Timeline

Recall initiated: 2022-11-17
Posted by FDA: 2023-02-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #197858. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.