| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | November 21, 2024 |
|---|
| Date Posted | December 30, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0788-2025 |
|---|
| Recall Event ID |
95852 |
| 510(K)Number | K213481 |
|---|
| Product Classification |
General surgery tray - Product Code LRO
|
| Product | See DocMan |
|---|
| Code Information |
1) REF CDS930177C, UDI/DI 10889942810949 (EA) 40889942810940 (CS), Lot Numbers: 19BBO293, 19CBI818, 19EBC020, 19IBS311, 19JBP366, 19LBY043, 19VBE320, 20CBD448, 21ABE744, 21BBN653;
2) REF CDS982054V, UDI/DI 10193489552799 (EA) 40193489552790 (CS), Lot Numbers: 19BBJ530, 19CBL695, 19EBN805, 19EBZ133;
3) REF CDS982683X, UDI/DI 10198459064548 (EA) 40198459064549 (CS), Lot Numbers: 24IBH460;
4) REF CDS982719X, UDI/DI 10198459064531 (EA) 40198459064532 (CS), Lot Numbers: 24IBE288, 24JBB766, 24KBA129;
5) REF CDS983467J, UDI/DI 10195327561116 (EA) 40195327561117 (CS), Lot Numbers: 24ADA818, 24ADC216, 24BDA929, 24DDB447, 24EDA275, 24EDA751, 24GDB213, 24IDA327, 24IDB043, 24IDB372;
6) REF CDS983470C, UDI/DI 10889942730407 (EA) 40889942730408 (CS), Lot Numbers: 19ADC620, 19BDA241, 19CDA866, 19DDA314, 19DDD395, 19FDB295, 19GDA719, 19HDD614, 19JDB841, 19LDB812;
7) REF CDS983470I, UDI/DI 10195327561154 (EA) 40195327561155 (CS), Lot Numbers:
23LDA393, 24ADC171, 24DDA672, 24EDB254, 24FDC148, 24IDB368;
8) REF CDS983799D, UDI/DI 10193489592030 (EA) 40193489592031 (CS), Lot Numbers: 19FKB592, 19HKC268, 19IKA490, 19IKB968, 19JKA055, 19KKC040, 19LKB631, 20CKA736, 20HKB175, 21FLA865, 21ILA106, 21KLA781, 22ILA060, 22ILA292, 23HLA184;
9) REF CDS985212A, UDI/DI 10193489596335 (EA) 40193489596336 (CS), Lot Numbers: 19ABY900, 19FBT060, 19IBL327, 19PBA051;
10) REF CDS985212B, UDI/DI 10193489779820 (EA) 40193489779821 (CS), Lot Numbers: 19LBU107, 19VBH315, 20BBO078, 20CBW525, 20DBT438, 20GBH006, 20IBN419, 21ABB097;
11) REF DYNDA2792, UDI/DI 10193489823325 (EA) 40193489823326 (CS), Lot Numbers: 21BBJ965, 21DBT050, 21EBE485;
12) REF DYNJ0140935G, UDI/DI 10889942930296 (EA) 40889942930297 (CS), Lot Numbers: 19ABO819, 19CBJ281, 19FBH068, 19GBZ882, 19HBV422, 19IBG846, 19JBL457, 20ABG080, 20CBD873, 20DBC392, 20FBA716, 20GBK071, 20HBR714, 20IBM990, 21ABP831, 21BBR277, 21DBA991;
13) REF DYNJ0281906P, UDI/DI 10889942867486 (EA) 40889942867487 (CS), Lot Numbers: 19AKB833, 19BKD052, 19CKC664, 19EKB037, 19FKC611, 19HKA221, 19IBO633, 19JBL228, 19KBW884, 20ABW509, 20DBG478, 20FBR142, 20HBK316, 20KBV694, 20WBF601, 21ABP539, 21CBQ956, 21DBJ886, 21EBS055, 21GBV942, 21GBV943, 21JBK514, 21KBB922, 21LBP163;
14) REF DYNJ0545720F, UDI/DI 10889942868162 (EA) 40889942868163 (CS), Lot Numbers: 23HBL391;
15) REF DYNJ0622014R, UDI/DI 10195327638283 (EA) 40195327638284 (CS), Lot Numbers: 24CMC296, 24CMJ807, 24DMG748, 24FMG704, 24FMI251, 24HMA703, 24HMG319;
16) REF DYNJ0622359T, UDI/DI 10889942854950 (EA) 40889942854951 (CS), Lot Numbers: 19CKA784, 19DKB029, 19EKB672, 19FKC958, 19IKA282, 19KKA347, 20AKA456, 20DKA893, 20GKA154, 20IKB236, 20KBJ261, 20LBF167, 21DBE536, 21HMB057, 21JMC983, 21LMC084, 22AMG399, 22CMF086, 22DMF723, 22FME590, 22GMF247, 22HMD803, 22HMH932, 22LMI805, 23CMC419, 23CMH936, 23EMC564, 23EMI551, 23FMI582, 23GMF661, 23HMF195, 23JMC894, 23KMI370, 23LMF894, 24BMB597, 24BMI540, 24DMC362, 24EMA548, 24EMG836, 24GMA030, 24GMF763, 24GMI854, 24HMI567, 24HMI955;
17) REF DYNJ0622386Q, UDI/DI 10889942854929 (EA) 40889942854920 (CS), Lot Numbers: 19AKB508, 19BKB297, 19CKB851, 19EKB548, 19GKC077, 19IKC118, 19LKA280, 20AKA093, 20BKB540, 20CKA744;
18) REF DYNJ0717887AJ, UDI/DI 10195327638450 (EA) 40195327638451 (CS), Lot Numbers: 24CBL730, 24FBS344, 24HBA541;
19) REF DYNJ0785885J, UDI/DI 10193489330281 (EA) 40193489330282 (CS), Lot Numbers: 21KBO465;
20) REF DYNJ0842793F, UDI/DI 10193489345230 (EA) 40193489345231 (CS), Lot Numbers: 20JDC651, 21CDA191, 21CDC092, 21EDA769, 21GDB289, 21HDC822, 22BDB295, 22DDA792, 22IDC164;
21) REF DYNJ0843063I, UDI/DI 10889942825806 (EA) 40889942825807 (CS), Lot Numbers:
19AKC945, 19CKA409, 19DKA921, 19GKC470, 19IDC371, 19IKA338, 19JDC795, 19LDC715, 20BDB414;
22) REF DYNJ0843063J, UDI/DI 10193489345377 (EA) 40193489345378 (CS), Lot Numbers: 20FDB087, 20GDB047, 20KDA566, 20LDB848, 21CDA233, 21EDC220, 21GDC682, 21IDA570, 21JDA064, 21LDA151, 22ADC136, 22CDB166, 22EDA616, 22FDB836, 22HDB150, 22KDA481;
23) REF DYNJ0843339K, UDI/DI 10889942938681 (EA) 40889942938682 (CS), Lot Numbers: 19BKA691, 19CKC840, 19DKA951, 19GKA288, 19HKB083, 19IDA720, 19KDA058, 20ADA961, 20CDA389;
24) REF DYNJ0843898D, UDI/DI 10889942826063 (EA) 40889942826064 (CS), Lot Numbers: 19AKB944, 19CKB282, 19FKC382, 19GKC853, 19IDC426, 20DDA276;
25) REF DYNJ0867427C, UDI/DI 10889942431120 (EA) 40889942431121 (CS), Lot Numbers: 19CDD368, 19FDB700, 19HDC811, 19HDD453, 19LMB365;
26) REF DYNJ0966146D, UDI/DI 10889942930357 (EA) 40889942930358 (CS), Lot Numbers: 19ABO709, 19CBA580, 19EBF354, 19GBT295, 19KBY442, 19QBC889, 19VBB032, 20ABO857, 20DBU994, 20HBL920, 20LBW570, 21ABP412;
27) REF DYNJ0991320I, UDI/DI 10888277788794 (EA) 40888277788795 (CS), Lot Numbers: 19AKA796;
28) REF DYNJ33643K, UDI/DI 10889942575954 (EA) 40889942575955 (CS), Lot Numbers: 19EKB989;
29) REF DYNJ34573C, UDI/DI 10888277735088 (EA) 40888277735089 (CS), Lot Numbers:
19BDA813, 19DDB567, 19GDA730;
30) REF DYNJ35418I, UDI/DI 10195327363550 (EA) 40195327363551 (CS), Lot Numbers: 23HMD662;
31) REF DYNJ36222D, UDI/DI 10889942885701 (EA) 40889942885702 (CS), Lot Numbers: 19BBO720, 19CBP760, 19CBQ117, 19EBL829, 19FBC341, 19GBE939, 19HBW847, 19IBM020, 19KBM388, 19KBT320, 19LBT685, 19QBB990, 20BBH792, 20BBM537, 20CBX800, 20DBI976, 20DBJ233, 20FBI175, 20HBJ636, 20KBQ223, 20KBU538, 21ABK832, 21CBS768, 21DBT715, 21FBE204, 21GBW101, 21IBN778, 21KBZ923, 21LBU606, 22EBH855, 22HBZ185, 22IBS175, 22OBG728, 24CBI282, 24DBP793, 24EBG249;
32) REF DYNJ39779A, UDI/DI 10193489670745 (EA) 40193489670746 (CS), Lot Numbers: 21ADA892;
33) REF DYNJ40611G, UDI/DI 10198459035319 (EA) 40198459035310 (CS), Lot Numbers: 24GBC745, 24HBQ529;
34) REF DYNJ40640B, UDI/DI 10193489292145 (EA) 40193489292146 (CS), Lot Numbers: 20BBX596, 20DBO449, 20EBB205, 20FBN575, 20HMC534, 20IME019, 20JMD705, 21AMC740, 21FME774, 21HMB307, 21IME326, 21JMA530, 21LMA424, 21LMF322, 22AMB866;
35) REF DYNJ41525K, UDI/DI 10889942930685 (EA) 40889942930686 (CS), Lot Numbers: 18LBJ507, 19ABQ505, 19ABS152, 19BBK025, 19BBL623, 19EBT852, 19HBC336, 19IBP753, 19JBL639, 19KBR980, 19LBP664, 19LBR109, 19VBG282, 20BBN072, 20BBX860, 20CBE032, 20EBM250, 20FBL617, 20GBN215, 20HBN509, 20LBA504, 20LBC589, 20LBH138;
36) REF DYNJ41575G, UDI/DI 10889942931095 (EA) 40889942931096 (CS), Lot Numbers: 19ABI643, 19DBE778, 19EBH045, 19FBI053, 19JBI536, 19KBN844, 20BBY030, 20FBB333, 20HBI785, 20IBJ221, 20JBE187, 21BBF460, 21BBO779, 21DBM102, 21HBC823, 21KBA852, 21KBV702;
37) REF DYNJ41862B, UDI/DI 10889942271870 (EA) 40889942271871 (CS), Lot Numbers: 19CBH891;
38) REF DYNJ41862C, UDI/DI 10193489676921 (EA) 40193489676922 (CS), Lot Numbers: 19HBB186, 19IBG399, 21ABN528, 21FBB410, 21KBK517, 22BBJ943, 22EBP039, 23FBE298, 23HBG086, 23KBF154, 23KBU312, 24GBG173;
39) REF DYNJ43862F, UDI/DI 10889942763290 (EA) 40889942763291 (CS), Lot Numbers: 19DLA181;
40) REF DYNJ44208I, UDI/DI 10195327425173 (EA) 40195327425174 (CS), Lot Numbers: 23HLA267;
41) REF DYNJ46759F, UDI/DI 10889942544165 (EA) 40889942544166 (CS), Lot Numbers: 19ABR340, 19CBL511, 19DBD264, 19GBA406, 19GBT422, 19IBG571, 19JBF953, 19KBK293, 20BBA489, 20BBN862, 20FBL340, 20HBN866, 21IBD081, 21JBU745, 21LBD905, 22BBZ823, 22CBM993, 22DBC234, 22KBB425, 22OBE132, 23ABL321, 23BBN467, 23CBM925, 23HBY458, 23KBT762, 23LBM948, 24ABN407, 24CBP525, 24EBV165, 24FBR373, 24IBF362;
42) REF DYNJ46776C, UDI/DI 10889942893218 (EA) 40889942893219 (CS), Lot Numbers: 19CBI414, 19EBL519, 19IBN157, 19JBW723, 19KBC678, 19KBU245, 20ABK590, 20FBO197, 20GBL383, 20IBS489, 20VBA358, 21BBE822, 21CBF297, 21GBA380;
43) REF DYNJ48508B, UDI/DI 10889942973422 (EA) 40889942973423 (CS), Lot Numbers: 19BBR134, 19DBH067, 19KBA794, 19LBF469, 19SBE627, 20ABN205, 20CBM788, 20FBN041, 20JBJ408, 21BBD901, 21CBZ860, 21DBG004, 21KBF676, 21LBU225, 22ABC625, 22BBX099, 22FBD970, 22HBE132, 22HBE998, 23BBE708, 23BBG089, 23CBA346, 23DBF697, 23FBH392, 23GBM157, 23KBR040, 23LBK369, 23LBU940, 24EBD548, 24FBB160;
44) REF DYNJ48513A, UDI/DI 10888277751477 (EA) 40888277751478 (CS), Lot Numbers:
19JBT525, 20LBZ539, 21ABM800, 21BBP988, 21CBO059, 21CBT625, 21EBA383, 21EBS002;
45) REF DYNJ48526A, UDI/DI 10888277751934 (EA) 40888277751935 (CS), Lot Numbers: 19ABF047, 19ABR209, 19CBM983, 19DBT046, 19HBH190, 19IBJ023, 19JBB854, 19LBT641, 19TBB034, 20ABA330, 20CBU020, 20JBD974, 20JBS084, 21LBA583;
46) REF DYNJ49620A, UDI/DI 10889942822201 (EA) 40889942822202 (CS), Lot Numbers: 19ADC873, 19DDB467, 19JDD031, 19LDA487, 20BDA780, 20CDB615, 20HDC279, 20KDB081, 20KDC126, 21GDA013, 21HDA815, 21IDA440, 21IDB352, 21JDB731, 22CDB685, 22FDA102, 22GDB538, 22LDA337, 23BDA775, 23CDC024, 23FDB113, 23HDA255, 23IDC001, 24BDA414, 24DDA197, 24FDA398, 24GDB731;
47) REF DYNJ50015C, UDI/DI 10889942930654 (EA) 40889942930655 (CS), Lot Numbers: 19BKC223, 19CKB032, 19DKA432, 19GKA863, 19HKA111, 19JKB339, 19LKB250, 20CKA540, 20FKA821, 20GKB469, 20HKC150;
48) REF DYNJ50499B, UDI/DI 10193489532227 (EA) 40193489532228 (CS), Lot Numbers: 19EDA686, 19FDC865, 19IDC387, 20ADD273;
49) REF DYNJ50692B, UDI/DI 10889942935505 (EA) 40889942935506 (CS), Lot Numbers: 19ADC424;
50) REF DYNJ50826A, UDI/DI 10889942861187 (EA) 40889942861188 (CS), Lot Numbers: 19ADD269, 19DDB211, 19FDC250, 19IDB089, 19JMB279, 19KMA144, 19KMC210, 20AMA374, 20BMB143, 20CMC805, 20GMA742, 20HMA637, 20HMD914, 21BME505, 21CMD532, 21FMB109, 21GMF096, 21IMH647, 21JMF341, 21LMG621, 22KMH198, 22LME815, 23EMB918, 23KBN786, 23LBL980, 24DBJ186, 24FBB505, 24HBL415;
51) REF DYNJ51421A, UDI/DI 10193489601114 (EA) 40193489601115 (CS), Lot Numbers: 19BDC973, 19DDD283;
52) REF DYNJ51441C, UDI/DI 10198459004292 (EA) 40198459004293 (CS), Lot Numbers: 24GMA812;
53) REF DYNJ51818G, UDI/DI 10193489613971 (EA) 40193489613972 (CS), Lot Numbers: 19BBJ134, 19PBA411;
54) REF DYNJ51835C, UDI/DI 10195327646899 (EA) 40195327646890 (CS), Lot Numbers: 24CBQ543, 24DBH650, 24EBL683, 24GBB766, 24HBL367;
55) REF DYNJ52792C, UDI/DI 10193489338386 (EA) 40193489338387 (CS), Lot Numbers: 20ELA756, 20FLA348, 20HLA934, 20ILA027, 20JLA092, 20JLA449, 20JLA490, 20LLA642, 21ELA032, 21GLB122, 21JLA936, 21KLA129, 21KLA890, 22CLB002, 22CLB271, 22FLA709, 23ALA274, 23DLA838, 23ELA466, 23FLB102, 23GLB165, 23JLA638, 23KLB049, 24CLA232, 24GLA388;
56) REF DYNJ54242A, UDI/DI 10193489579697 (EA) 40193489579698 (CS), Lot Numbers: 19BBP835, 21ABF223, 21GBE671, 21LBP487;
57) REF DYNJ54719B, UDI/DI 10889942923137 (EA) 40889942923138 (CS), Lot Numbers: 19ABJ755, 19BBA696, 19DBR800, 19DBT388, 19FBM738, 19GBS978, 19JBJ249, 19LBD659, 19TBC880, 20BBS356, 20DBJ594, 20EBU691, 20FBM664;
58) REF DYNJ54740B, UDI/DI 10889942925490 (EA) 40889942925491 (CS), Lot Numbers: 19ABM969, 19CBO190, 19EBO486, 19EBP225, 19FBQ144, 19GBO818;
59) REF DYNJ54749B, UDI/DI 10889942921614 (EA) 40889942921615 (CS), Lot Numbers: 19ABA058, 19CBJ541, 19DBG441, 19EBI446, 19EBI477, 19GBQ173, 19GBU621;
60) REF DYNJ54749C, UDI/DI 10193489779097 (EA) 40193489779098 (CS), Lot Numbers: 19IBD755, 19LBA265, 20ABJ851, 20BBU632, 20CBH241, 20GBC319, 20GBD104, 20GBG005, 20GBS281, 20HBE279;
61) REF DYNJ54761A, UDI/DI 10889942921775 (EA) 40889942921776 (CS), Lot Numbers: 19CBD919, 19CBO191, 19GBE012, 19IBN910, 19JBQ109, 19LBC686, 20BBC135, 20BBS156, 20BBS968, 20DBQ604, 20EBN905, 20IBB772;
62) REF DYNJ55474C, UDI/DI 10888277750883 (EA) 40888277750884 (CS), Lot Numbers: 19ABW549, 19CBP105, 19GBG525, 19HBG485, 19IBO737, 19JBT391, 19JBW839, 19KBB564, 19KBY433, 20ABQ304, 20CBL058, 20EBD930, 20FBG467, 20JBT022, 20VBB472, 21CBX141, 21EBA746, 21IBW048, 21JBO552, 21KBY266, 22BBF592;
63) REF DYNJ56798A, UDI/DI 10889942933242 (EA) 40889942933243 (CS), Lot Numbers: 19CBU410, 19JBF959, 19LBI493, 20GBF989, 21FBJ053;
64) REF DYNJ56893A, UDI/DI 10888277759794 (EA) 40888277759795 (CS), Lot Numbers: 18LDC678, 19ADA205, 19ADA294, 19DDA531, 20AMA262, 20AMB806, 20DMB167, 20GMB030, 20KMC261, 21AME257, 21EME731, 21GMC107, 21IMA008, 21JMC035;
65) REF DYNJ57136, UDI/DI 10889942720248 (EA) 40889942720249 (CS), Lot Numbers: 19AKD626, 19CKD783, 19EKD455, 19HKB046, 19JKA372, 20AKA943, 20DKA790, 20FKA598, 20HKA406, 21ABN524, 21ABP762, 21ABS829, 21BBQ777, 21CBD799;
66) REF DYNJ57198A, UDI/DI 10888277761360 (EA) 40888277761361 (CS), Lot Numbers: 19ABX372, 19FBN100, 19GBR121, 19IBL614, 19IBR552, 19JBD171, 19LBP759, 20CBV279, 20FBL222, 20GBK094, 21ABL082, 21DBE424, 21FBT110, 21HBL857, 21IBC891, 21JBC004, 21LBR884, 22BBT257, 22BBT260, 22BBU548, 23ABH976, 23DBB780, 23EBC342, 23HBU005, 23JBS002, 23LMD346, 24BME900, 24EMC172, 24GMB582, 24IMA383;
67) REF DYNJ57233D, UDI/DI 10195327493455 (EA) 40195327493456 (CS), Lot Numbers: 23JLA873;
68) REF DYNJ57257, UDI/DI 10889942733255 (EA) 40889942733256 (CS), Lot Numbers: 19FBX075, 20ABA607, 20JBB123, 22JBD206, 23DBB728, 23GBH055, 24BBG537, 24GBJ900;
69) REF DYNJ57555A, UDI/DI 10193489568998 (EA) 40193489568999 (CS), Lot Numbers: 19ABY380, 19VBD258, 20CBI055, 20DBO362, 20FBS410, 20GBF597, 21ABE355, 21FBG575, 21JBI499, 22EBA191, 22IBP288, 23ABL325, 23CBP433, 23GBH903, 24FBD183;
70) REF DYNJ57770, UDI/DI 10889942776818 (EA) 40889942776819 (CS), Lot Numbers: 19BBC132, 19CBD245;
71) REF DYNJ57788, UDI/DI 10889942777433 (EA) 40889942777434 (CS), Lot Numbers: 19ABS651, 19EDB882, 19FDA729, 19IDA254, 19JDA667, 20ADB297, 20CDC512, 20EDA135, 20EDA738, 20GDA306, 20HDA357, 20LDA597, 21CDC056, 21DDC163, 21IDB960, 21JDA737, 22BDA414, 22DDB022, 22EDB819, 22GDA970, 22IDA244, 22IDA746, 23ADB650, 23ADB771, 23EDB807, 23FDC142, 23GDA661;
72) REF DYNJ57971A, UDI/DI 10889942937318 (EA) 40889942937319 (CS), Lot Numbers: 19AKC450, 19BKD079, 19DKA190, 19EKB858, 19FKC211, 19GKC271, 19IMA702, 19KMC226, 20AMB792, 20CMB987, 20FMB207, 20HMD678, 21AMB802, 21BMB315, 21DMA436, 21GMA642, 21IMA722, 21JMH024;
73) REF DYNJ58087, UDI/DI 10889942817733 (EA) 40889942817734 (CS), Lot Numbers: 19ADC329, 19CDA069, 19CDA115, 19EDD304, 19GDC111, 19HDC512, 19KMA570, 19LMA487, 20AMA094, 20BMC462, 20EMB074, 20FMB980, 20HMD135, 20JMB238, 21BMD988, 21DMB994, 21EMA604, 21GMD287, 21HMB332, 21IMF523;
74) REF DYNJ58293A, UDI/DI 10889942960620 (EA) 40889942960621 (CS), Lot Numbers: 19ABW401, 19DBE192, 19FBK630, 19GBS108, 19HBW827, 19JBD506, 19WBB560, 20BBO659;
75) REF DYNJ58534, UDI/DI 10889942864881 (EA) 40889942864882 (CS), Lot Numbers: 19ADA090, 19ADD493, 19CDC664, 19EDB222, 19HDB096, 19JDA323, 20ADA944, 20ADD309, 20CDC666, 20EDA159, 20FDA866, 20GDB840, 20IDC205, 21ADA543, 21BDB930, 21DDA362, 21EDB507, 21FDB625, 21GDD250, 21IDB176, 21KDB846, 22ADA093, 22DDA013, 22FDA167, 22FDB137, 22GDA405, 22IDB347, 23ADB689, 23BDB992, 23DDB625, 23FDB355, 23HDA932, 23IDA729, 23KDA105, 24ADA739, 24CDC059, 24EDB122, 24FDB180, 24GDB206, 24IDA334;
76) REF DYNJ58856, UDI/DI 10889942907120 (EA) 40889942907121 (CS), Lot Numbers: 19ABB994, 19ABH064, 19CBM059, 19DBU960, 19FBY332;
77) REF DYNJ58857, UDI/DI 10889942906840 (EA) 40889942906841 (CS), Lot Numbers: 19CBC777, 19DBS625;
78) REF DYNJ58953, UDI/DI 10193489656015 (EA) 40193489656016 (CS), Lot Numbers: 19DBK800, 19FBQ501, 19HBR173, 20ABW574, 20BBD242;
79) REF DYNJ58987A, UDI/DI 10888277763975 (EA) 40888277763976 (CS), Lot Numbers: 19DBU718;
80) REF DYNJ59018, UDI/DI 10889942921652 (EA) 40889942921653 (CS), Lot Numbers: 19KBL492;
81) REF DYNJ59257, UDI/DI 10888277771819 (EA) 40888277771810 (CS), Lot Numbers: 19KLA376;
82) REF DYNJ59449, UDI/DI 10888277742345 (EA) 40888277742346 (CS), Lot Numbers: 19BKC125, 19CKB724, 19CKD787, 19FKB852;
83) REF DYNJ59740A, UDI/DI 10193489764468 (EA) 40193489764469 (CS), Lot Numbers: 19IBE725, 21VBB135;
84) REF DYNJ59906, UDI/DI 10888277793316 (EA) 40888277793317 (CS), Lot Numbers: 19ABK161, 19BBT652, 19EBC452, 19FBQ643, 19GBU642, 19SBF517, 19VBA082, 19WBB320, 20ABQ966, 20ABR922, 20BBY027, 21JBC991;
85) REF DYNJ59906A, UDI/DI 10195327038366 (EA) 40195327038367 (CS), Lot Numbers: 21LBL543;
86) REF DYNJ60048, UDI/DI 10888277796201 (EA) 40888277796202 (CS), Lot Numbers: 19GBU314, 19IBH746, 19KBG952, 19RBA250, 19TBC056, 19VBF237, 20CBI867, 20FBT845, 20IBI782, 20IBM126, 20LBW595, 20WBH517, 21ABP411, 21JBP418, 21KBI717, 21LBA251, 22ABC466, 23ABE006, 23BBM451, 23BBQ090, 23EBK151, 23IBO983, 24ABP913;
87) REF DYNJ60048A, UDI/DI 10195327628406 (EA) 40195327628407 (CS), Lot Numbers: 24BBL588;
88) REF DYNJ60048B, UDI/DI 10198459023606 (EA) 40198459023607 (CS), Lot Numbers: 24EBV916, 24FBB172, 24FBC781, 24FBH867, 24GBR286;
89) REF DYNJ60308, UDI/DI 10889942972937 (EA) 40889942972938 (CS), Lot Numbers: 19ABX143, 19CBC188, 19FBG750;
90) REF DYNJ60700, UDI/DI 10193489523492 (EA) 40193489523493 (CS), Lot Numbers: 19ABP285, 19BBJ367, 19FBY972;
91) REF DYNJ61174, UDI/DI 10193489547344 (EA) 40193489547345 (CS), Lot Numbers: 19ALA473, 19CLA347, 19ELA022, 19FLA055, 19GLA045, 19GLA579, 19JLA672, 20ALA610, 20BLA503, 20CLA530, 20ELA070, 20ELA086, 20HLA070, 20JLA203, 20JLA623, 20LLA194, 21CLA148;
92) REF DYNJ61429, UDI/DI 10193489565942 (EA) 40193489565943 (CS), Lot Numbers: 19ABP298;
93) REF DYNJ61607A, UDI/DI 10193489665734 (EA) 40193489665735 (CS), Lot Numbers: 19DDA988, 19DDB002, 19LBM308, 20ALA490, 20BLA183, 20CLA436, 20DLA247, 20ELA374, 20FLA460, 20GLA287, 20HLA189, 20JLA575, 21ALA279, 21ALA552, 21BLA327, 21CLA471, 21DLA357, 21ELA242, 21GLB002, 21ILA929, 21JLB057, 22ALA023, 22CLA971, 22ELB151, 22FLA458, 22FLB055, 22GLA826, 22ILA719, 22KLA801, 23BLA374, 23BLB085, 23DLA400, 23ELA020, 23ELA565, 23ILA093, 23LLA093, 23LLA533, 24ALA247, 24ALA834, 24BLB042, 24FLA031, 24FLA670, 24GLA731, 24ILA505;
94) REF DYNJ62163, UDI/DI 10193489631067 (EA) 40193489631068 (CS), Lot Numbers: 19BBN554, 19EBM067, 19GBH547, 19HBA848, 19IBV781, 19KBH337, 19PBA138, 19VBA998, 20BBU195, 20DBP660, 20DBS244, 20FBM348, 20FBR163, 20GBT592, 20HBH240, 20IMA443, 20JBL627, 21CBY798, 21DBR900;
95) REF DYNJ62635, UDI/DI 10193489674972 (EA) 40193489674973 (CS), Lot Numbers: 19FKA701, 19HKD272, 19JKB414, 20CKA304, 20FKC091, 20JKA171;
96) REF DYNJ62635A, UDI/DI 10193489446401 (EA) 40193489446402 (CS), Lot Numbers: 20KMD018, 20LMB396, 21IMB322, 21JME655, 22CMF169, 22KMD276, 23AMA922, 23BMD206, 23BMH636, 23DME221, 23EMF242, 23KMB495;
97) REF DYNJ63315, UDI/DI 10193489736601 (EA) 40193489736602 (CS), Lot Numbers: 19SBC357, 20ABL380;
98) REF DYNJ63322, UDI/DI 10193489735550 (EA) 40193489735551 (CS), Lot Numbers: 19HBB762, 20DBH238, 20VBB403;
99) REF DYNJ64755, UDI/DI 10193489217155 (EA) 40193489217156 (CS), Lot Numbers: 19KDC066, 20CDB793, 20CDC655, 20EDA143;
100) REF DYNJ66104, UDI/DI 10193489320114 (EA) 40193489320115 (CS), Lot Numbers: 20DBA269, 21ABL056, 21BBD271, 21HBU165, 21IBQ745, 21JBV201, 22DBT642, 22EBD114;
101) REF DYNJ66252C, UDI/DI 10195327573508 (EA) 40195327573509 (CS), Lot Numbers: 24ABT457, 24BBN976;
102) REF DYNJ66252D, UDI/DI 10195327665371 (EA) 40195327665372 (CS), Lot Numbers:
24DBN478, 24EBB279, 24GBE883, 24HBE336, 24IBD364;
103) REF DYNJ66419C, UDI/DI 10198459059353 (EA) 40198459059354 (CS), Lot Numbers: 24IBG439;
104) REF DYNJ66450, UDI/DI 10193489356809 (EA) 40193489356800 (CS), Lot Numbers: 20EBN858, 20HBI496, 20HBN158, 20HBW094, 20IBM040, 20JBE532, 21CBZ632, 21KBJ072, 21KBJ077, 22DBB798;
105) REF DYNJ66867, UDI/DI 10193489390162 (EA) 40193489390163 (CS), Lot Numbers: 20KBA210, 21CBI593, 21CBI878, 21CBO619, 21DBN186, 21DBR346, 21FBK533, 21FBK560;
106) REF DYNJ67143F, UDI/DI 10195327349516 (EA) 40195327349517 (CS), Lot Numbers: 23CBI420, 23DBI928, 23EBE571, 23FBN880, 23GBO149;
107) REF DYNJ67284, UDI/DI 10193489394603 (EA) 40193489394604 (CS), Lot Numbers: 20HBL326, 21ABL436, 21ABR896, 21CBP256;
108) REF DYNJ67360, UDI/DI 10193489886306 (EA) 40193489886307 (CS), Lot Numbers: 21FBL510, 21KBG982, 21LBS763, 22DBT264;
109) REF DYNJ68536D, UDI/DI 10195327648541 (EA) 40195327648542 (CS), Lot Numbers: 24BMJ672, 24CME419, 24DMG494;
110) REF DYNJ68536F, UDI/DI 10198459019944 (EA) 40198459019945 (CS), Lot Numbers: 24FMI354, 24HMH484, 24IMC850;
111) REF DYNJ69907, UDI/DI 10193489995558 (EA) 40193489995559 (CS), Lot Numbers: 21KMF842, 22CMI433, 22DMD639, 22EMA026;
112) REF DYNJ69907A, UDI/DI 10195327163976 (EA) 40195327163977 (CS), Lot Numbers: 22FMB386, 22GMB441;
113) REF DYNJ69907B, UDI/DI 10195327352653 (EA) 40195327352654 (CS), Lot Numbers: 23EMC223, 23EMH340, 23HMC692;
114) REF DYNJ69907C, UDI/DI 10195327511920 (EA) 40195327511921 (CS), Lot Numbers: 23IMI023, 23LMA198, 24AMB620, 24AMI444, 24FMF025, 24GME354;
115) REF DYNJ81010A, UDI/DI 10195327590840 (EA) 40195327590841 (CS), Lot Numbers: 24CBN274, 24DBV550;
116) REF DYNJ82007A, UDI/DI 10195327635466 (EA) 40195327635467 (CS), Lot Numbers: 24CMA496, 24HMI081, 24HMI978, 24IME319;
117) REF DYNJ82008A, UDI/DI 10195327630416 (EA) 40195327630417 (CS), Lot Numbers: 24DMD092;
118) REF DYNJ82011A, UDI/DI 10195327635480 (EA) 40195327635481 (CS), Lot Numbers: 24BMJ118, 24EMD223, 24FMD601, 24GMB190, 24GMJ808, 24HMI979;
119) REF DYNJ82222, UDI/DI 10195327183776 (EA) 40195327183777 (CS), Lot Numbers: 22IDA854, 22LDA908, 23BDB094, 23CDA416, 23EDB704, 23FDC245, 23HDA808, 23JME953;
120) REF DYNJ82897B, UDI/DI 10195327655112 (EA) 40195327655113 (CS), Lot Numbers: 24CBQ530, 24EBR125, 24HBN077;
121) REF DYNJ82913C, UDI/DI 10195327655150 (EA) 40195327655151 (CS), Lot Numbers: 24CBN015;
122) REF DYNJ82913F, UDI/DI 10195327695101 (EA) 40195327695102 (CS), Lot Numbers: 24EBH336, 24FBO324, 24FBO906, 24GBK285, 24HBJ081;
123) REF DYNJ84068, UDI/DI 10195327332143 (EA) 40195327332144 (CS), Lot Numbers: 23HLA314, 23HLA583, 23HLB152, 23LLA069, 24ALA297, 24ALA391, 24BLA384;
124) REF DYNJ84106, UDI/DI 10195327332587 (EA) 40195327332588 (CS), Lot Numbers: 23HDB358;
125) REF DYNJ84215, UDI/DI 10195327343286 (EA) 40195327343287 (CS), Lot Numbers: 23DBF729, 23EBG615, 23GBG763, 23HBC841, 24ABE845, 24DBH682, 24EBR657, 24GBE319, 24HBS172, 24HBT847;
126) REF DYNJ84310A, UDI/DI 10195327629243 (EA) 40195327629244 (CS), Lot Numbers: 24GBC568;
127) REF DYNJ84389A, UDI/DI 10195327455446 (EA) 40195327455447 (CS), Lot Numbers: 23FLB067, 23ILA476, 23ILA940, 23JLA844;
128) REF DYNJ84389C, UDI/DI 10198459063145 (EA) 40198459063146 (CS), Lot Numbers:
24HLA821;
129) REF DYNJ85324A, UDI/DI 10195327660598 (EA) 40195327660599 (CS), Lot Numbers: 24CBJ589, 24DBK509;
130) REF DYNJ85873, UDI/DI 10195327561826 (EA) 40195327561827 (CS), Lot Numbers: 24BLA781;
131) REF DYNJ86403, UDI/DI 10195327629908 (EA) 40195327629909 (CS), Lot Numbers: 24DBG240;
132) REF DYNJ86657, UDI/DI 10195327666767 (EA) 40195327666768 (CS), Lot Numbers: 24EBD920;
133) REF DYNJ86868, UDI/DI 10195327686680 (EA) 40195327686681 (CS), Lot Numbers: 24GMD128;
134) REF DYNJ87109, UDI/DI 10198459013119 (EA) 40198459013110 (CS), Lot Numbers: 24FLA291;
135) REF DYNJ87116, UDI/DI 10198459013188 (EA) 40198459013189 (CS), Lot Numbers: 24FMD547;
136) REF DYNJ900212J, UDI/DI 10195327280499 (EA) 40195327280490 (CS), Lot Numbers: 22LBL842, 23ABD311, 23DBM829, 23HBN516, 23IBV048, 23JBV025;
137) REF DYNJ900212K, UDI/DI 10195327539931 (EA) 40195327539932 (CS), Lot Numbers: 24BBD853, 24CBA352, 24FBJ907, 24GBB632, 24HBQ189;
138) REF DYNJ900727B, UDI/DI 10889942730612 (EA) 40889942730613 (CS), Lot Numbers: 19CDC859, 19FDA004, 19HDA362, 19HDD144, 19IDC602, 19LDC040;
139) REF DYNJ901247D, UDI/DI 10889942824717 (EA) 40889942824718 (CS), Lot Numbers: 19ABH620, 19CBJ486, 19FBJ024, 19HBS119, 19KBN130, 20ABU138, 20EBF850, 20HBO213, 20JBQ486, 20LBS219, 21CBB698, 21EBO586, 21IBT341, 21KBW693;
140) REF DYNJ901572J, UDI/DI 10193489601930 (EA) 40193489601931 (CS), Lot Numbers: 19BBT466, 19EBN488, 19SBE596;
141) REF DYNJ902223O, UDI/DI 10198459064524 (EA) 40198459064525 (CS), Lot Numbers: 24GBP237, 24HBW570, 24IBR806;
142) REF DYNJ902398C, UDI/DI 10889942815319 (EA) 40889942815310 (CS), Lot Numbers: 19ABL747, 19BBE413, 19CBH307, 19EBI390;
143) REF DYNJ902443A, UDI/DI 10889942911691 (EA) 40889942911692 (CS), Lot Numbers: 19DBV400, 19EBU658, 19FBH718, 19HBT516, 19IBC498.19JBB632, 19KBJ356, 20BBC576;
144) REF DYNJ902468D, UDI/DI 10889942910922 (EA) 40889942910923 (CS), Lot Numbers: 19CBE962;
145) REF DYNJ903118A, UDI/DI 10889942666584 (EA) 40889942666585 (CS), Lot Numbers: 19BKC713, 19DKB859, 19EKC707, 19FKA491, 19GKB959, 19JKB131, 19KKB861, 19LKB813, 20AKC061, 20EKB819;
146) REF DYNJ903432C, UDI/DI 10889942897360 (EA) 40889942897361 (CS), Lot Numbers: 19BBU598, 19CBT718;
147) REF DYNJ903433C, UDI/DI 10889942897070 (EA) 40889942897071 (CS), Lot Numbers: 19ABH743, 19BBI667, 19DBY175;
148) REF DYNJ903433D, UDI/DI 10193489667240 (EA) 40193489667241 (CS), Lot Numbers: 19EBR630, 19GBL873, 19HBA116, 19JBM659, 19TBA493, 20ABZ268, 20BBW543, 20DBU226, 20EBU277, 20GBF068, 20IBH032, 20LBR712, 21EBG495, 21FBA038, 21GBO959, 21HBG922, 21KBL545, 21LBJ680, 22ABR745, 22CBT517, 22CBU888, 22DBC126, 22GBC494, 22GBF929, 22IBA031, 22IBQ245, 22IBQ246, 22JBQ950, 22NBC138, 23ABM825;
149) REF DYNJ903438C, UDI/DI 10889942896936 (EA) 40889942896937 (CS), Lot Numbers: 19ABL753, 19BBF425, 19CBV094;
150) REF DYNJ903439C, UDI/DI 10889942898176 (EA) 40889942898177 (CS), Lot Numbers: 19BBM916, 19CBO426;
151) REF DYNJ903439D, UDI/DI 10193489667233 (EA) 40193489667234 (CS), Lot Numbers: 19EBH987, 19GBS290, 19JBX126, 19LBB739, 19TBD294, 20ABJ951, 20CBD268, 20DBK863, 20EBI905, 20GBJ903, 20JBK109, 20WBA963, 20XBD654, 21DBI979, 21FBN629, 21HBD985, 21IBJ227, 21JBV737, 21JBZ207, 22ABT592;
152) REF DYNJ903452C, UDI/DI 10889942897353 (EA) 40889942897354 (CS), Lot Numbers: 19ABV484, 19CBH300;
153) REF DYNJ903453B, UDI/DI 10889942897964 (EA) 40889942897965 (CS), Lot Numbers: 19ABP326, 19ABU260, 19DBL516;
154) REF DYNJ903453C, UDI/DI 10193489667837 (EA) 40193489667838 (CS), Lot Numbers: 19FBB789, 19JBB962, 19KBH862, 19LBC736, 20BBA652, 20DBL302, 20EBV109, 20IBD336, 20KBU099, 20WBA964, 21CBI800, 21DBI926, 21DBT247, 21IBD614, 21VBD132, 22CBB814, 22CBB826, 22DBB658;
155) REF DYNJ903619C, UDI/DI 10888277761551 (EA) 40888277761552 (CS), Lot Numbers: 19IBZ082, 19KBJ361;
156) REF DYNJ903621B, UDI/DI 10888277761575 (EA) 40888277761576 (CS), Lot Numbers: 19DBC252, 19DBX014, 19GBB373;
157) REF DYNJ903687C, UDI/DI 10888277740686 (EA) 40888277740687 (CS), Lot Numbers: 19BBJ692, 19DBJ425;
158) REF DYNJ903687D, UDI/DI 10193489654318 (EA) 40193489654319 (CS), Lot Numbers: 19FBZ901, 19KBK664, 20DBB501;
159) REF DYNJ904595C, UDI/DI 10889942963423 (EA) 40889942963424 (CS), Lot Numbers: 19SBH080;
160) REF DYNJ904990A, UDI/DI 10193489297706 (EA) 40193489297707 (CS), Lot Numbers: 20CKB565, 20LKA184;
161) REF DYNJ905082B, UDI/DI 10193489782646 (EA) 40193489782647 (CS), Lot Numbers: 19KBG621, 20ABF571, 20BBH276, 20BBW923, 20EBK711, 20GBU624, 21HBQ010, 21HBU956, 21HBU957, 21JBK045, 21KBL606, 21LBW287, 22BBQ888, 22BLA832;
162) REF DYNJ905365, UDI/DI 10889942905959 (EA) 40889942905950 (CS), Lot Numbers: 19ABV620, 19BBO391, 19DBF885, 19EBS511, 19FBS349, 19GBK660, 19HBJ659;
163) REF DYNJ905366, UDI/DI 10889942905966 (EA) 40889942905967 (CS), Lot Numbers: 19CBM149, 19DBN665, 19GBJ917;
164) REF DYNJ905383, UDI/DI 10889942907649 (EA) 40889942907640 (CS), Lot Numbers: 19ABV476, 19BBQ458, 19HBJ660, 19PBA048, 19RBA313;
165) REF DYNJ905384, UDI/DI 10889942907625 (EA) 40889942907626 (CS), Lot Numbers: 19ABN848, 19BBQ183, 19DBN800, 19EBE405, 19GBC503, 19GBL109;
166) REF DYNJ905385, UDI/DI 10889942906369 (EA) 40889942906360 (CS), Lot Numbers: 19ABT892, 19CBJ109, 19DBS189, 19EBY157, 19GBL870;
167) REF DYNJ905616, UDI/DI 10888277774780 (EA) 40888277774781 (CS), Lot Numbers: 19BBN713;
168) REF DYNJ905634, UDI/DI 10888277778214 (EA) 40888277778215 (CS), Lot Numbers:
19ABX742;
169) REF DYNJ906448G, UDI/DI 10198459056178 (EA) 40198459056179 (CS), Lot Numbers: 24GBY479, 24IBA847;
170) REF DYNJ906472J, UDI/DI 10195327541743 (EA) 40195327541744 (CS), Lot Numbers: 23KDC448, 23LDB171, 24CDC080, 24EDA648, 24EDB032, 24FDA457, 24GDB107, 24IDA280;
171) REF DYNJ906495G, UDI/DI 10195327541750 (EA) 40195327541751 (CS), Lot Numbers: 23LDA597, 24EDA260, 24GDA741;
172) REF DYNJ906496G, UDI/DI 10195327565978 (EA) 40195327565979 (CS), Lot Numbers: 24ALA040, 24ALB047, 24BLA277, 24ELA089, 24HLA251;
173) REF DYNJ906795B, UDI/DI 10195327247171 (EA) 40195327247172 (CS), Lot Numbers: 22KBF267, 23CBD744, 23EBJ145, 23FBL943, 23JBB249, 23KBW098, 23LBE718;
174) REF DYNJ906809A, UDI/DI 10193489867794 (EA) 40193489867795 (CS), Lot Numbers: 21DBK192, 22GBX677, 22IBA667, 22IBG722, 22KBD382, 23ABU449, 23GBR721, 23IBI925, 23IBS506, 23JBT778, 23JBT779;
175) REF DYNJ906839, UDI/DI 10193489263091 (EA) 40193489263092 (CS), Lot Numbers: 20CBU635, 20EBB650, 20FBL979, 20GBU487, 20HBW530, 20KBE313, 21ABL363, 21EBQ838, 21HBC500, 21IBI422, 21JBQ449, 21LBT082, 22BBM536;
176) REF DYNJ906839B, UDI/DI 10195327694203 (EA) 40195327694204 (CS), Lot Numbers: 24GMD369, 24HMH385, 24IMA551;
177) REF DYNJ907802A, UDI/DI 10195327244408 (EA) 40195327244409 (CS), Lot Numbers: 23JBS085;
178) REF DYNJ907817A, UDI/DI 10193489977011 (EA) 40193489977012 (CS), Lot Numbers: 21HBT251, 21IBO418, 23EBB458, 24CBL740;
179) REF DYNJ907817B, UDI/DI 10195327668877 (EA) 40195327668878 (CS), Lot Numbers: 24DBH098, 24DBR260;
180) REF DYNJ908000B, UDI/DI 10195327031954 (EA) 40195327031955 (CS), Lot Numbers: 21KBW899;
181) REF DYNJ908821, UDI/DI 10195327185633 (EA) 40195327185634 (CS), Lot Numbers: 22IDA868, 23FDB839;
182) REF DYNJ908833, UDI/DI 10195327186524 (EA) 40195327186525 (CS), Lot Numbers: 22LDA882, 23EDA843;
183) REF DYNJ909111C, UDI/DI 10195327458546 (EA) 40195327458547 (CS), Lot Numbers: 23GBK299, 23IBH549, 23JBC432, 23JBV427, 23KBP827;
184) REF DYNJ909111D, UDI/DI 10195327587901 (EA) 40195327587902 (CS), Lot Numbers: 24BBI817, 24CBB595, 24DBH342, 24DBT662, 24EBL358, 24FBC420, 24FBR785, 24GBX710, 24IBN033;
185) REF DYNJ909361A, UDI/DI 10195327660789 (EA) 40195327660780 (CS), Lot Numbers: 24FME885, 24GMB076,24GMG213;
186) REF DYNJ909364A, UDI/DI 10195327660420 (EA) 40195327660421 (CS), Lot Numbers: 24EMH357, 24FMD768, 24GMA069, 24IMB155, 24IMD666;
187) REF DYNJ910059, UDI/DI 10195327560836 (EA) 40195327560837 (CS), Lot Numbers: 24CBV367, 24DBB005, 24GBB520;
188) REF DYNJ910072B, UDI/DI 10198459011085 (EA) 40198459011086 (CS), Lot Numbers: 24GBB034, 24HBI964;
189) REF DYNJ910073B, UDI/DI 10198459011191 (EA) 40198459011192 (CS), Lot Numbers: 24FBC549, 24GBR785;
190) REF DYNJ910240, UDI/DI 10195327618247 (EA) 40195327618248 (CS), Lot Numbers: 24CBC764, 24DBF366, 24GBE949, 24HBB501, 24HBW205, 24IBD734;
191) REF DYNJ910467, UDI/DI 10195327699512 (EA) 40195327699513 (CS), Lot Numbers:
24FBM948, 24GBG498, 24IBR833;
192) REF SG270B, UDI/DI 10193489421491 (EA) 40193489421492 (CS), Lot Numbers: 23HBP960;
193) REF SYNJ10265A, UDI/DI 10888277997202 (EA) 40888277997203 (CS), Lot Numbers: 19DBO965, 19HBV333.
|
Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
|
| For Additional Information Contact | Haley Barclay
866-359-1704 |
|---|
Manufacturer Reason
for Recall | Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination. |
|---|
FDA Determined
Cause 2 | Nonconforming Material/Component |
|---|
| Action | Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit. |
|---|
| Quantity in Commerce | 65310 units |
|---|
| Distribution | Worldwide distribution - US Nationwide and the countries of UAE, and Canada. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = LRO
|
|---|
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